{ "FullStudy":{ "Rank":218132, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512316", "OrgStudyIdInfo":{ "OrgStudyId":"IMDCSACQEXT" }, "Organization":{ "OrgFullName":"Universitaire Ziekenhuizen Leuven", "OrgClass":"OTHER" }, "BriefTitle":"Exploring Learning and Unlearning of Fear", "OfficialTitle":"The Effect of D-cycloserine on Fear Learning and Extinction" }, "StatusModule":{ "StatusVerifiedDate":"December 2011", "OverallStatus":"Unknown status", "LastKnownStatus":"Not yet recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StudyFirstSubmitDate":"December 22, 2011", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 13, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 19, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Universitaire Ziekenhuizen Leuven", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The present study investigates the effect of d-cycloserine on learning and unlearning of fear in healthy humans and its underlying effect on the amygdala.\n\nAs a second objective, the effect of genotype on fear learning will be studied.", "DetailedDescription":"A growing body of evidence suggests that the extinction of fear is mediated by the N-methyl-D-aspartate (NMDA) receptor activity in the basolateral amygdala. Intra-amygdala infusions of antagonists of this glutamate receptor in small animals (eg: rats, mice) have demonstrated a blockage of fear acquisition and extinction. Agonists, on the other hand, facilitate conditioned fear extinction.\n\nThe animal studies are all based on the simple fear learning paradigm of conditioning. However, it is not clear that human anxiety disorders are based on prior conditioning encounter. Therefore it is important to disentangle the effect of DCS on acquisition and extinction in the context of a simple learning paradigm, particular its effect on the human amygdala." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Healthy Individuals" ] }, "KeywordList":{ "Keyword":[ "Fear", "Cycloserine", "Conditioning", "Functional neuroimaging", "Anxiety disorders" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Basic Science", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"90", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"d-Cycloserine Acquisition", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"d-Cycloserine will be given on day1, before acquisition", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: d-Cycloserine", "Genetic: Saliva sample", "Other: Functional neuroimaging (fMRI)" ] } },{ "ArmGroupLabel":"d-Cycloserine Extinction", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"d-Cycloserine will be administered on day2, before extinction", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: d-Cycloserine", "Genetic: Saliva sample", "Other: Functional neuroimaging (fMRI)" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"A placebo pill will be administered on day1 and 2", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lactose pill", "Genetic: Saliva sample", "Other: Functional neuroimaging (fMRI)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"d-Cycloserine", "InterventionDescription":"250mg, one dose, 2hrs prior to fMRI", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "d-Cycloserine Acquisition", "d-Cycloserine Extinction" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Cycloserine, King Pharmaceuticals Ltd" ] } },{ "InterventionType":"Drug", "InterventionName":"Lactose pill", "InterventionDescription":"one dose, 2hrs prior to fmri", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } },{ "InterventionType":"Genetic", "InterventionName":"Saliva sample", "InterventionDescription":"Buccal cell material will be sampled from all participants on day3", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo", "d-Cycloserine Acquisition", "d-Cycloserine Extinction" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Whatman's Sterile Omni Swabs (www.whatman.com)" ] } },{ "InterventionType":"Other", "InterventionName":"Functional neuroimaging (fMRI)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo", "d-Cycloserine Acquisition", "d-Cycloserine Extinction" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"change in BOLD-signal during a fear conditioning task", "PrimaryOutcomeDescription":"Subjects will participate in a 3-day experiment. Day1 (t0): Acquisition Day2 (T+24): extinction Day3 (T+48): re-exposure", "PrimaryOutcomeTimeFrame":"t0, t+24, t+48" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nNo axis I diagnosis compatible with the DSM-IV by means of a structured diagnostic interview\nRight-handed\n\nExclusion Criteria:\n\nCurrent psychopharmacological or psychological treatment.\nThe presence of a physical/medical condition that may interfere with the study.\nA contraindication for the use of DCS\nPacemaker, medication pump (such as insulin pump), hearing aid, removable prosthodontics\nMetal in or on body (such as acupuncture needles, artificial limbs, stents, metal splints, clips, implanted electrodes, tattoos, or piercings)", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"40 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Liesbet Goossens, PhD", "CentralContactRole":"Contact", "CentralContactPhone":"+31 43 3685306", "CentralContactEMail":"lies.goossens@maastrichtuniversity.nl" },{ "CentralContactName":"Stefan Sunaert, MD PhD", "CentralContactRole":"Contact", "CentralContactPhone":"+32 16 349021", "CentralContactEMail":"stefan.sunaert@uz.kuleuven.be" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Catholic University Leuven, Departement of Radiology", "LocationCity":"Leuven", "LocationZip":"3000", "LocationCountry":"Belgium", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Stefan Sunaert, MD PhD", "LocationContactRole":"Contact", "LocationContactPhone":"+32 16 349021", "LocationContactEMail":"stefan.sunaert@uz.kuleuven.be" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000003523", "InterventionMeshTerm":"Cycloserine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000892", "InterventionAncestorTerm":"Anti-Infective Agents, Urinary" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000012076", "InterventionAncestorTerm":"Renal Agents" },{ "InterventionAncestorId":"D000000904", "InterventionAncestorTerm":"Antibiotics, Antitubercular" },{ "InterventionAncestorId":"D000000995", "InterventionAncestorTerm":"Antitubercular Agents" },{ "InterventionAncestorId":"D000000900", "InterventionAncestorTerm":"Anti-Bacterial Agents" },{ "InterventionAncestorId":"D000000963", "InterventionAncestorTerm":"Antimetabolites" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M5312", "InterventionBrowseLeafName":"Cycloserine", "InterventionBrowseLeafAsFound":"Cycloserine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2805", "InterventionBrowseLeafName":"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2892", "InterventionBrowseLeafName":"Antitubercular Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2862", "InterventionBrowseLeafName":"Antimetabolites", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"Rena", "InterventionBrowseBranchName":"Renal Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M2905", "ConditionBrowseLeafName":"Anxiety Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }