{ "FullStudy":{ "Rank":217953, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514682", "OrgStudyIdInfo":{ "OrgStudyId":"HP-00051603; 11T-002" }, "Organization":{ "OrgFullName":"University of Maryland, Baltimore", "OrgClass":"OTHER" }, "BriefTitle":"Anti-Inflammatory Treatment of Schizophrenia", "OfficialTitle":"Anti-Inflammatory Combination Therapy for the Treatment of Schizophrenia" }, "StatusModule":{ "StatusVerifiedDate":"May 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 17, 2017", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 17, 2017", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 4, 2018", "ResultsFirstSubmitQCDate":"February 28, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 29, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"October 31, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 4, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Robert Buchanan", "ResponsiblePartyInvestigatorTitle":"Chief, Maryland Psychiatric Research Center, Outpatient Research Program", "ResponsiblePartyInvestigatorAffiliation":"University of Maryland, College Park" }, "LeadSponsor":{ "LeadSponsorName":"University of Maryland, Baltimore", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Despite current antipsychotic treatment, the majority of people with schizophrenia continue to exhibit persistent positive and negative symptoms and cognitive impairments. An alternative approach to the use of psychotropic agents for the treatment of persistent symptoms is the use of anti-inflammatory agents to reverse the pro-inflammatory state hypothesized to underlie the symptom and sign manifestations of the illness.\n\nThe investigators primary hypothesis is that add-on anti-inflammatory combination therapy will have significant beneficial effects on persistent positive symptoms and cognitive impairments.\n\nThe investigators secondary hypotheses are:\n\nadd-on anti-inflammatory combination therapy will be associated with improvements in depressive and negative symptoms and a reduction in pro-inflammatory cytokines\nadd-on anti-inflammatory combination therapy compared to placebo will not be associated with elevated adverse risk.", "DetailedDescription":"Schizophrenia has been hypothesized to be due, in part, to disruptions of normal immune system and inflammatory responses to viral or bacterial infections or other stimuli of these systems. Epidemiological and clinical studies have provided extensive evidence that perinatal exposure to infection contributes to the etiology of schizophrenia. The recent reports of associations between markers of single nucleotide polymorphisms located within the major histocompatibility complex on chromosome 6p22.1 and schizophrenia provide further support for etiological hypotheses of immune system dysfunction in schizophrenia.\n\nThere are a large number of reports that suggest that people with schizophrenia have altered cytokine levels, with one or more studies reporting elevated levels of the pro-inflammatory cytokines: IL-1β, IL-6, IL-12, CRP, IFN-γ, and TNF-α; and reduced levels of the anti-inflammatory cytokine: IL-10. In this study we examine the use of combination anti-inflammatory therapy as an intervention in patients with schizophrenia. We will use\n\nSalsalate, 4 gm/day. Salsalate is a potent inhibitor of nuclear transcription factor NF-κB activation. NF-κB is activated by pro-inflammatory cytokines;\nOmega-3-fatty acids eicosapentaenoic (EPA; 2 gm/day) and docosahexaenoic (DHA; 2 gm/day). Omega-3-fatty acids exert their anti-inflammatory effects through their oxygenation into resolvins or protectins, which are potent anti-inflammatory agents;\nFluvastatin, 40 mgs/day. Fluvastatin is a lipid-lowering drugs, which acts through the inhibition of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA). Fluvastatin may also exert anti-inflammatory effects independent of its lipid-lowering effects via a mechanism involving HMG-CoA inhibition and decreased NF-κB activation.\n\nWe have chosen to use combination therapy with three different classes of anti-inflammatory agents to address the potential benefit of this therapeutic approach for persistent positive symptoms and cognitive impairments. The three agents have unique anti-inflammatory mechanisms of action, which we believe offers the most robust evaluation of this therapeutic approach and maximizes the likelihood of eliciting pronounced therapeutic effects." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Schizophrenia" ] }, "KeywordList":{ "Keyword":[ "schizophrenia", "anti-inflammatory", "salsalate", "statins", "omega-3-fatty acids" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"50", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo pills to be assigned using a permuted randomization system", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"Anti-inflammatory Combination Therapy", "ArmGroupType":"Experimental", "ArmGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Anti-inflammatory Combination Therapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Anti-inflammatory Combination Therapy", "InterventionDescription":"salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening\nfluvastatin: target dose 40 mg/day, administered in a single evening dose\ncombined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Anti-inflammatory Combination Therapy" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Non-medication pills; To be taken in morning and evening intervals.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Persistent Positive Symptoms", "PrimaryOutcomeDescription":"The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from \"1=Not Present\" to \"7=Very Severe\". The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating.", "PrimaryOutcomeTimeFrame":"The BPRS will be administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks." },{ "PrimaryOutcomeMeasure":"Change in Neuropsychological Test Performance", "PrimaryOutcomeDescription":"The MATRICS Consensus Cognitive Battery (MCCB) composite score by week ranging from -10-100 with a higher score indicating a better outcome.", "PrimaryOutcomeTimeFrame":"The MCCB was administered at baseline and end-of-study (Week 12)." } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in Depressive Symptoms", "SecondaryOutcomeDescription":"The Calgary Depression Scale (CDS) total score will be used to measure depressive symptoms. Total score calculated by adding scores for scales #1-#9. Each scale ranges from \"0=Absent\" to \"3=Severe\". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.", "SecondaryOutcomeTimeFrame":"The CDS was administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks." },{ "SecondaryOutcomeMeasure":"Change in Negative Symptoms", "SecondaryOutcomeDescription":"The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Median SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.", "SecondaryOutcomeTimeFrame":"Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks." },{ "SecondaryOutcomeMeasure":"Change in Pro-inflammatory Cytokines", "SecondaryOutcomeDescription":"Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.", "SecondaryOutcomeTimeFrame":"A cytokine profile will be collected at baseline and at week 12 (end-of-study)." },{ "SecondaryOutcomeMeasure":"Change in C-Reactive Protein (CRP)", "SecondaryOutcomeDescription":"Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.", "SecondaryOutcomeTimeFrame":"A cytokine profile will be collected at baseline and at week 12 (end-of-study)." } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nParticipants will meet DSM-IV-TR criteria for schizophrenia or schizoaffective disorder.\n\nParticipants will be required to meet the following symptom criteria:\n\nBPRS total score of 45 or greater on the 18 item version (scale: 1-7) or a Clinical Global Impression (CGI) severity of illness item score of 4 (moderate) or greater.\nBPRS positive symptom item total score of 8 or greater and a score of 4 or more on at least one individual item.\nParticipants will be clinically stable, be treated with the same antipsychotic for at least 60 days and a constant therapeutic dose for at least 30 days prior to study entry.\nParticipants must be judged competent to participate in the informed consent process and provide voluntary informed consent\n\nExclusion Criteria:\n\nParticipants who meet DSM-IV-TR criteria for alcohol or substance dependence (except nicotine) within the last 6 months or DSM-IV-TR criteria for alcohol or substance abuse (except nicotine) within the last month will be excluded\nParticipants with a current infection or an organic brain disorder or medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol will be excluded.\nParticipants with a history of: aspirin allergy, pre-existing tinnitus, tuberculosis, HIV, or hepatitis C; or autoimmune disease.\nParticipants who are currently treated with a statin, warfarin, dipyridamole, or other anti-coagulants.\nParticipant is currently treated with an omega-3-fatty acid preparation and cannot discontinue their use of the preparation for the duration of the study.\nFemale participant who is sexually active and not using any form of birth control such as oral contraceptives or IUDs.\nFemale participant who is pregnant or breastfeeding.\nParticipant with current/active peptic ulcer disease or gastritis; anemia or thrombocytopenia (platelet count ≤120).\nParticipant who is currently treated with a medication that can increase the risk of myopathy and rhabdomyolysis such as Fluconazole, Ketoconazole, Colchicine, Daptomycin, Erythromycin, or immunosuppressants that alter statin levels.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"60 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Robert W Buchanan, MD", "OverallOfficialAffiliation":"University of Maryland, College Park", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"William T Carpenter, MD", "OverallOfficialAffiliation":"University of Maryland, College Park", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Maryland Psychiatric Research Center", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21228", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Signed a consent form: 52 (50 unique subjects: 2 withdrew then later re-enrolled, not counted in analysis); Ineligible prior to Evaluation Phase: 1 subject (1=clinically unstable); Entered Evaluation Phase: 49 subjects; Withdrawn prior to randomization: 10 (8=Did not meet BPRS criteria; 1=Did not meet age criteria; 1=On an excluded medication)", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Anti-inflammatory Combination Therapy", "FlowGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"Placebo pills to be assigned using a permuted randomization system\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose\n\nPlacebo: Non-medication pills; To be taken in morning and evening intervals." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"19" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"20" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"13" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Physician Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Anti-inflammatory Combination Therapy", "BaselineGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"Placebo pills to be assigned using a permuted randomization system\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose\n\nPlacebo: Non-medication pills; To be taken in morning and evening intervals." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"19" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"20" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"39" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"39" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"27" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Ethnicity (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"18" } ] } },{ "BaselineCategoryTitle":"Not Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"20" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"15" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"19" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"39" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in Persistent Positive Symptoms", "OutcomeMeasureDescription":"The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from \"1=Not Present\" to \"7=Very Severe\". The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating.", "OutcomeMeasurePopulationDescription":"Participants completing the BPRS assessment rating.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"The BPRS will be administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo pills to be assigned using a permuted randomization system\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose\n\nPlacebo: Non-medication pills; To be taken in morning and evening intervals." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Anti-inflammatory Combination Therapy", "OutcomeGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline Week 0", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13", "OutcomeMeasurementLowerLimit":"12", "OutcomeMeasurementUpperLimit":"16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"12", "OutcomeMeasurementUpperLimit":"15" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"11", "OutcomeMeasurementUpperLimit":"16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"11", "OutcomeMeasurementUpperLimit":"18" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"10", "OutcomeMeasurementUpperLimit":"16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15", "OutcomeMeasurementLowerLimit":"11", "OutcomeMeasurementUpperLimit":"16" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"11", "OutcomeMeasurementUpperLimit":"16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"12", "OutcomeMeasurementUpperLimit":"15" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 8", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12", "OutcomeMeasurementLowerLimit":"10", "OutcomeMeasurementUpperLimit":"16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"10", "OutcomeMeasurementUpperLimit":"17" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 10", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"10", "OutcomeMeasurementUpperLimit":"15" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"10", "OutcomeMeasurementUpperLimit":"16" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14", "OutcomeMeasurementLowerLimit":"10", "OutcomeMeasurementUpperLimit":"15" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12", "OutcomeMeasurementLowerLimit":"10", "OutcomeMeasurementUpperLimit":"14" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in Neuropsychological Test Performance", "OutcomeMeasureDescription":"The MATRICS Consensus Cognitive Battery (MCCB) composite score by week ranging from -10-100 with a higher score indicating a better outcome.", "OutcomeMeasurePopulationDescription":"Participants completing the MCCB testing.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"The MCCB was administered at baseline and end-of-study (Week 12).", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo pills to be assigned using a permuted randomization system\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose\n\nPlacebo: Non-medication pills; To be taken in morning and evening intervals." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Anti-inflammatory Combination Therapy", "OutcomeGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"19" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline Week 0", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"25", "OutcomeMeasurementLowerLimit":"18.5", "OutcomeMeasurementUpperLimit":"35" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"36", "OutcomeMeasurementLowerLimit":"24", "OutcomeMeasurementUpperLimit":"48.5" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"24", "OutcomeMeasurementLowerLimit":"20", "OutcomeMeasurementUpperLimit":"29.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"26", "OutcomeMeasurementLowerLimit":"13.8", "OutcomeMeasurementUpperLimit":"41.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Depressive Symptoms", "OutcomeMeasureDescription":"The Calgary Depression Scale (CDS) total score will be used to measure depressive symptoms. Total score calculated by adding scores for scales #1-#9. Each scale ranges from \"0=Absent\" to \"3=Severe\". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.", "OutcomeMeasurePopulationDescription":"Participants completing the CDS assessment rating.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"The CDS was administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo pills to be assigned using a permuted randomization system\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose\n\nPlacebo: Non-medication pills; To be taken in morning and evening intervals." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Anti-inflammatory Combination Therapy", "OutcomeGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"19" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline Week 0", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0.5", "OutcomeMeasurementUpperLimit":"3.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"2" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1", "OutcomeMeasurementLowerLimit":"0.75", "OutcomeMeasurementUpperLimit":"2" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1", "OutcomeMeasurementLowerLimit":"0.25", "OutcomeMeasurementUpperLimit":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"2.5" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"1", "OutcomeMeasurementUpperLimit":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"3" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 8", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"1", "OutcomeMeasurementUpperLimit":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"1" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 10", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"1" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"1.8" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Negative Symptoms", "OutcomeMeasureDescription":"The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Median SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.", "OutcomeMeasurePopulationDescription":"Participants completing the SANS rating assessment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo pills to be assigned using a permuted randomization system\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose\n\nPlacebo: Non-medication pills; To be taken in morning and evening intervals." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Anti-inflammatory Combination Therapy", "OutcomeGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"19" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline Week 0", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"27", "OutcomeMeasurementLowerLimit":"24", "OutcomeMeasurementUpperLimit":"30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"26", "OutcomeMeasurementLowerLimit":"19", "OutcomeMeasurementUpperLimit":"34" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28", "OutcomeMeasurementLowerLimit":"23", "OutcomeMeasurementUpperLimit":"33" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"24", "OutcomeMeasurementLowerLimit":"20", "OutcomeMeasurementUpperLimit":"30" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"32", "OutcomeMeasurementLowerLimit":"25", "OutcomeMeasurementUpperLimit":"34" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"30", "OutcomeMeasurementLowerLimit":"20", "OutcomeMeasurementUpperLimit":"34" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28", "OutcomeMeasurementLowerLimit":"21", "OutcomeMeasurementUpperLimit":"34" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"27", "OutcomeMeasurementLowerLimit":"23", "OutcomeMeasurementUpperLimit":"30" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 8", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30", "OutcomeMeasurementLowerLimit":"25", "OutcomeMeasurementUpperLimit":"36" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"24", "OutcomeMeasurementLowerLimit":"19", "OutcomeMeasurementUpperLimit":"34" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 10", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30", "OutcomeMeasurementLowerLimit":"24", "OutcomeMeasurementUpperLimit":"33" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"30", "OutcomeMeasurementLowerLimit":"17", "OutcomeMeasurementUpperLimit":"32" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28", "OutcomeMeasurementLowerLimit":"22", "OutcomeMeasurementUpperLimit":"34" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28", "OutcomeMeasurementLowerLimit":"19", "OutcomeMeasurementUpperLimit":"32" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Pro-inflammatory Cytokines", "OutcomeMeasureDescription":"Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.", "OutcomeMeasurePopulationDescription":"Participants who had a cytokine profile collected.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"pg/ml", "OutcomeMeasureTimeFrame":"A cytokine profile will be collected at baseline and at week 12 (end-of-study).", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo pills to be assigned using a permuted randomization system\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose\n\nPlacebo: Non-medication pills; To be taken in morning and evening intervals." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Anti-inflammatory Combination Therapy", "OutcomeGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"19" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline IL-2 levels", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"59.16", "OutcomeMeasurementSpread":"88.38" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"34.94", "OutcomeMeasurementSpread":"77.01" } ] } } ] } },{ "OutcomeClassTitle":"End of study IL-2 levels", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"88.4", "OutcomeMeasurementSpread":"146.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"47.5", "OutcomeMeasurementSpread":"86.0" } ] } } ] } },{ "OutcomeClassTitle":"Baseline IL-8 levels", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.16", "OutcomeMeasurementSpread":"5.59" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.35", "OutcomeMeasurementSpread":"4.59" } ] } } ] } },{ "OutcomeClassTitle":"End of study IL-8 levels", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.91", "OutcomeMeasurementSpread":"7.24" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"19.78", "OutcomeMeasurementSpread":"46.91" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in C-Reactive Protein (CRP)", "OutcomeMeasureDescription":"Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.", "OutcomeMeasurePopulationDescription":"Participants who had a cytokine profile collected.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng/ml", "OutcomeMeasureTimeFrame":"A cytokine profile will be collected at baseline and at week 12 (end-of-study).", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo pills to be assigned using a permuted randomization system\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose\n\nPlacebo: Non-medication pills; To be taken in morning and evening intervals." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Anti-inflammatory Combination Therapy", "OutcomeGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"19" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline CRP levels", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"38953", "OutcomeMeasurementSpread":"27218" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"42950", "OutcomeMeasurementSpread":"32468" } ] } } ] } },{ "OutcomeClassTitle":"End of study CRP levels", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"38759", "OutcomeMeasurementSpread":"21753" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"31849", "OutcomeMeasurementSpread":"23176" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"12-week Treatment Phase.", "EventsDescription":"Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.\n\nPsychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Placebo", "EventGroupDescription":"Placebo pills to be assigned using a permuted randomization system\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose\n\nPlacebo: Non-medication pills; To be taken in morning and evening intervals.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"20", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"20", "EventGroupOtherNumAffected":"10", "EventGroupOtherNumAtRisk":"20" },{ "EventGroupId":"EG001", "EventGroupTitle":"Anti-inflammatory Combination Therapy", "EventGroupDescription":"Salsalate, statin and omega-3-fatty acid combination therapy\n\nAnti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"19", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"19", "EventGroupOtherNumAffected":"14", "EventGroupOtherNumAtRisk":"19" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Hospitalization", "SeriousEventOrganSystem":"General disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventNotes":"Hospitalized for acute febrile illness and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome. The fever and rash were judged to be possibly study drug related. The SAE resolved upon discontinuation of the study drugs.", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"20" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"19" } ] } },{ "SeriousEventTerm":"Hospitalization", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"Hospitalization for worsening of clinical symptoms. The symptom exacerbation resolved with treatment.", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"20" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"19" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Eructation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"19" } ] } },{ "OtherEventTerm":"Abdominal pain", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"19" } ] } },{ "OtherEventTerm":"Tinnitus", "OtherEventOrganSystem":"Ear and labyrinth disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"19" } ] } },{ "OtherEventTerm":"Psychiatric symptom increase", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"8", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"19" } ] } },{ "OtherEventTerm":"Flatulence", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"20" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"19" } ] } },{ "OtherEventTerm":"High triglyceride levels", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { 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