{ "FullStudy":{ "Rank":217972, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514422", "OrgStudyIdInfo":{ "OrgStudyId":"GCO 11-0432" }, "Organization":{ "OrgFullName":"Icahn School of Medicine at Mount Sinai", "OrgClass":"OTHER" }, "BriefTitle":"Minocycline for Bipolar Depression", "OfficialTitle":"Minocycline for Bipolar Disorder" }, "StatusModule":{ "StatusVerifiedDate":"December 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"September 29, 2016", "ResultsFirstSubmitQCDate":"December 6, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 30, 2017", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 6, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 30, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Dan V. Iosifescu", "ResponsiblePartyInvestigatorTitle":"Associate Professor", "ResponsiblePartyInvestigatorAffiliation":"Icahn School of Medicine at Mount Sinai" }, "LeadSponsor":{ "LeadSponsorName":"Icahn School of Medicine at Mount Sinai", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate minocycline as a potential treatment for bipolar depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is approved for the treatment of infections and acne. Participation in this research study is expected to last 8 weeks, and includes five outpatient visits.", "DetailedDescription":"Bipolar depression remains the great unmet need in the treatment of bipolar disorder. Only two treatments have been FDA-approved for the management of acute bipolar depression (the combination of olanzapine and fluoxetine and quetiapine). Early pilot data suggests the drug minocycline has potent antidepressant effects. Minocycline is approved by the Food and Drug Administration (FDA) (for acne and bacterial infections), is inexpensive and readily available in generic formulation, and is generally well-tolerated. This study will examine whether administering the drug minocycline to individuals with bipolar depression over 8 weeks will improve their depressive symptoms. This study will also offer an option to participate in proton magnetic resonance spectroscopy (1H-MRS) to measure N-Acetylaspartate (NAA) levels in the brain, which are thought to be decreased in bipolar disorder." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Bipolar Depression" ] }, "KeywordList":{ "Keyword":[ "Bipolar disorder", "depression", "minocycline", "mood disorders", "bipolar depression" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"20", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Minocycline", "ArmGroupType":"Experimental", "ArmGroupDescription":"All subjects will be given minocycline over 8 weeks", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Minocycline" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Minocycline", "InterventionDescription":"Minocycline 100 to 300mg per day for 8 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Minocycline" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Minocin" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)", "PrimaryOutcomeDescription":"Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).", "PrimaryOutcomeTimeFrame":"baseline and week 8" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan", "SecondaryOutcomeDescription":"Measured at baseline and week 8", "SecondaryOutcomeTimeFrame":"baseline and week 8" },{ "SecondaryOutcomeMeasure":"Changes in Young Mania Rating Scale (YMRS)", "SecondaryOutcomeDescription":"Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania).", "SecondaryOutcomeTimeFrame":"baseline and week 8" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMeets DSM-IV criteria for Bipolar I Disorder or Bipolar II disorder, depressed phase\nA baseline score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS)\nParticipants on mood stabilizer medication for at least two weeks prior to starting the study, and must remain on the treatment during the study\nAble to understand English\n\nExclusion Criteria:\n\nDSM-IV diagnosis of Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type\nPregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)\nSerious suicide or homicide risk\nUnstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease\nClinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before visit 1\nDrug/alcohol dependence within past 30 days, or current substance use disorder that requires detoxification\nCurrent use of minocycline or history of anaphylactic reaction or intolerance to minocycline\nPrimary clinical diagnosis of antisocial or borderline personality disorder\nPatients with metallic foreign bodies or claustrophobia will be excluded from the MRS component", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"68 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Dan V Iosifescu, MD, MSc", "OverallOfficialAffiliation":"Icahn School of Medicine at Mount Sinai", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Icahn School of Medicine at Mount Sinai", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10029", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"Study procedures were conducted between June 2011 and June 2013 at the Mood and Anxiety Disorders Program at Icahn School of Medicine at Mount Sinai.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Minocycline", "FlowGroupDescription":"Minocycline 100 to 300mg per day for 8 weeks" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"20" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"19" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Minocycline", "BaselineGroupDescription":"Minocycline 100 to 300mg per day for 8 weeks" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"20" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"43.6", "BaselineMeasurementSpread":"12.7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Gender", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)", "OutcomeMeasureDescription":"Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"baseline and week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Minocycline", "OutcomeGroupDescription":"Minocycline for 8 weeks" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-14.6", "OutcomeMeasurementLowerLimit":"-21.3", "OutcomeMeasurementUpperLimit":"-7.8" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan", "OutcomeMeasureDescription":"Measured at baseline and week 8", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mmol/L", "OutcomeMeasureTimeFrame":"baseline and week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Minocycline", "OutcomeGroupDescription":"Minocycline for 8 weeks" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.001", "OutcomeMeasurementSpread":"0.0022" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Changes in Young Mania Rating Scale (YMRS)", "OutcomeMeasureDescription":"Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"baseline and week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Minocycline", "OutcomeGroupDescription":"Minocycline for 8 weeks" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.8", "OutcomeMeasurementSpread":"2.3" } ] } } ] } },{ "OutcomeClassTitle":"week 8", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.1", "OutcomeMeasurementSpread":"0.9" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Minocycline", "EventGroupDescription":"Minocycline for 8 weeks", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"20", "EventGroupOtherNumAffected":"20", "EventGroupOtherNumAtRisk":"20" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Frequent need to urinate", "OtherEventOrganSystem":"Renal and urinary disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Trouble sleeping", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Fee!ing drowsy or sleepy", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Dry mouth", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Muscle cramps or stiffness", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Diarrhea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Appetite increased", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Difficulties finding words", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Feeling nervous or hyper", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Irritable", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Feeling strange or unreal", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Stomach or abdominal discomfort", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Difficulty starting urination", "OtherEventOrganSystem":"Renal and urinary disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Weight gain", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Nightmares or other disturbances", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Weakness or fatigue", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Dizziness or faintness", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Drooling or increase salivation", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Nausea or vomiting", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Constipation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Problems with sexual arousal", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Delayed or absent orgasm", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Appetite decreased", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Skin rash or allergy", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Diminished mental acuity", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Apathy/emotional indifference", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Bruising", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Hot flashes", "OtherEventOrganSystem":"Endocrine disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Strange taste in mouth", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Unable to sit still", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } },{ "OtherEventTerm":"Function impairment", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"20" } ] } } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Dr. Dan V. Iosifescu", "PointOfContactOrganization":"Mood and Anxiety Disorders Program, Icahn School of Medicine at Mount Sinai", "PointOfContactEMail":"dan.iosifescu@mssm.edu", "PointOfContactPhone":"212-241-4480" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008911", "InterventionMeshTerm":"Minocycline" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000900", "InterventionAncestorTerm":"Anti-Bacterial Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M10462", "InterventionBrowseLeafName":"Minocycline", "InterventionBrowseLeafAsFound":"Minocycline", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003863", "ConditionMeshTerm":"Depression" },{ "ConditionMeshId":"D000003866", "ConditionMeshTerm":"Depressive Disorder" },{ "ConditionMeshId":"D000001714", "ConditionMeshTerm":"Bipolar Disorder" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001526", "ConditionAncestorTerm":"Behavioral Symptoms" },{ "ConditionAncestorId":"D000019964", "ConditionAncestorTerm":"Mood Disorders" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" },{ "ConditionAncestorId":"D000068105", "ConditionAncestorTerm":"Bipolar and Related Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5641", "ConditionBrowseLeafName":"Depression", "ConditionBrowseLeafAsFound":"Depression", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5644", "ConditionBrowseLeafName":"Depressive Disorder", "ConditionBrowseLeafAsFound":"Depression", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20419", "ConditionBrowseLeafName":"Mood Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3578", "ConditionBrowseLeafName":"Bipolar Disorder", "ConditionBrowseLeafAsFound":"Bipolar Depression", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3399", "ConditionBrowseLeafName":"Behavioral Symptoms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M226", "ConditionBrowseLeafName":"Bipolar and Related Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }