Nctid:
NCT00000371
Payload:
{"hasResults"=>true, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012559", "term"=>"Schizophrenia"}], "ancestors"=>[{"id"=>"D000019967", "term"=>"Schizophrenia Spectrum and Other Psychotic Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M15376", "name"=>"Schizophrenia", "asFound"=>"Schizophrenia", "relevance"=>"HIGH"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M21838", "name"=>"Schizophrenia Spectrum and Other Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"T6034", "name"=>"Quality of Life", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000003523", "term"=>"Cycloserine"}], "ancestors"=>[{"id"=>"D000000892", "term"=>"Anti-Infective Agents, Urinary"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000000904", "term"=>"Antibiotics, Antitubercular"}, {"id"=>"D000000995", "term"=>"Antitubercular Agents"}, {"id"=>"D000000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}, {"id"=>"M16904", "name"=>"Antipsychotic Agents", "relevance"=>"LOW"}, {"id"=>"M15512", "name"=>"Serotonin", "relevance"=>"LOW"}, {"id"=>"M18659", "name"=>"N-Methylaspartate", "relevance"=>"LOW"}, {"id"=>"M6729", "name"=>"Cycloserine", "asFound"=>"Phase III Study", "relevance"=>"HIGH"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"T3", "name"=>"Aspartic Acid", "relevance"=>"LOW"}, {"id"=>"T5", "name"=>"Glutamic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Amino Acids", "abbrev"=>"AA"}]}}, "resultsSection"=>{"moreInfoModule"=>{"pointOfContact"=>{"email"=>"goff@psych.mgh.harvard.edu", "phone"=>"617-921-7899", "title"=>"Dr. Donald Goff", "organization"=>"Freedom Clinic Trail, Massachusetts General Hospital"}, "certainAgreement"=>{"piSponsorEmployee"=>false, "restrictiveAgreement"=>false}, "limitationsAndCaveats"=>{"description"=>"A biased sample may have been produced by restricting the analysis to patients with prominent negative symptoms receiving conventional agents (less compliant with study medication). Additionally, Adverse Event data was lost for the study."}}, "adverseEventsModule"=>{"description"=>"The only information known for this study regarding occurrence of Adverse Events is that 2 and 6 participants dropped out of the D-Cycloserine and Placebo Arms/Groups, respectively (reported in the publication associated with this clinical trials profile). However, specific adverse event data are lost and cannot be retrieved", "eventGroups"=>[{"id"=>"EG000", "title"=>"D-Cycloserine", "description"=>"Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.", "otherNumAtRisk"=>0, "otherNumAffected"=>0, "seriousNumAtRisk"=>0, "seriousNumAffected"=>0}, {"id"=>"EG001", "title"=>"Placebo", "description"=>"Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.", "otherNumAtRisk"=>0, "otherNumAffected"=>0, "seriousNumAtRisk"=>0, "seriousNumAffected"=>0}], "frequencyThreshold"=>"0"}, "outcomeMeasuresModule"=>{"outcomeMeasures"=>[{"type"=>"PRIMARY", "title"=>"Scale for the Assessment of Negative Symptoms (SANS)", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"28", "groupId"=>"OG000"}, {"value"=>"27", "groupId"=>"OG001"}]}], "groups"=>[{"id"=>"OG000", "title"=>"D-Cycloserine", "description"=>"Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics."}, {"id"=>"OG001", "title"=>"Placebo", "description"=>"Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics."}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"-.46", "spread"=>".29", "groupId"=>"OG000"}, {"value"=>"-.41", "spread"=>".31", "groupId"=>"OG001"}]}]}], "paramType"=>"MEAN", "timeFrame"=>"Baseline, Week 4, Week 8", "description"=>"The slope of SANS total score from baseline to week 8 in the treatment and placebo groups on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The slopes were obtained by plotting the group SANS total score mean for treatment vs. placebo on Baseline, Week 4, and Week 8 and performing a random slopes model.", "unitOfMeasure"=>"units on a scale/weeks", "dispersionType"=>"Standard Error", "reportingStatus"=>"POSTED"}]}, "participantFlowModule"=>{"groups"=>[{"id"=>"FG000", "title"=>"D-Cycloserine", "description"=>"Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics."}, {"id"=>"FG001", "title"=>"Placebo", "description"=>"Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics."}], "periods"=>[{"title"=>"Overall Study", "milestones"=>[{"type"=>"STARTED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"27"}, {"groupId"=>"FG001", "numSubjects"=>"28"}]}, {"type"=>"COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"14"}, {"groupId"=>"FG001", "numSubjects"=>"12"}]}, {"type"=>"NOT COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"13"}, {"groupId"=>"FG001", "numSubjects"=>"16"}]}]}], "recruitmentDetails"=>"Subjects were adult outpatients recruited from three urban community health centers and two Veteran's Affairs medical centers in the greater Boston area. All eligible participants at these sites were invited to participate by their clinicians.", "preAssignmentDetails"=>"Sixty subjects met eligibility criteria and provided informed consent, but just 55 completed baseline assessments and were randomized to d-cycloserine or placebo."}, "baselineCharacteristicsModule"=>{"denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"27", "groupId"=>"BG000"}, {"value"=>"28", "groupId"=>"BG001"}, {"value"=>"55", "groupId"=>"BG002"}]}], "groups"=>[{"id"=>"BG000", "title"=>"D-Cycloserine", "description"=>"Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics."}, {"id"=>"BG001", "title"=>"Placebo", "description"=>"Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics."}, {"id"=>"BG002", "title"=>"Total", "description"=>"Total of all reporting groups"}], "measures"=>[{"title"=>"Age, Continuous", "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"45.9", "spread"=>"7.4", "groupId"=>"BG000"}, {"value"=>"47.0", "spread"=>"8.6", "groupId"=>"BG001"}, {"value"=>"46.5", "spread"=>"8.0", "groupId"=>"BG002"}]}]}], "paramType"=>"MEAN", "unitOfMeasure"=>"Years", "dispersionType"=>"STANDARD_DEVIATION"}, {"title"=>"Age, Categorical", "classes"=>[{"categories"=>[{"title"=>"<=18 years", "measurements"=>[{"value"=>"0", "groupId"=>"BG000"}, {"value"=>"0", "groupId"=>"BG001"}, {"value"=>"0", "groupId"=>"BG002"}]}, {"title"=>"Between 18 and 65 years", "measurements"=>[{"value"=>"27", "groupId"=>"BG000"}, {"value"=>"28", "groupId"=>"BG001"}, {"value"=>"55", "groupId"=>"BG002"}]}, {"title"=>">=65 years", "measurements"=>[{"value"=>"0", "groupId"=>"BG000"}, {"value"=>"0", "groupId"=>"BG001"}, {"value"=>"0", "groupId"=>"BG002"}]}]}], "paramType"=>"COUNT_OF_PARTICIPANTS", "unitOfMeasure"=>"Participants"}, {"title"=>"Sex: Female, Male", "classes"=>[{"categories"=>[{"title"=>"Female", "measurements"=>[{"value"=>"3", "groupId"=>"BG000"}, {"value"=>"8", "groupId"=>"BG001"}, {"value"=>"11", "groupId"=>"BG002"}]}, {"title"=>"Male", "measurements"=>[{"value"=>"24", "groupId"=>"BG000"}, {"value"=>"20", "groupId"=>"BG001"}, {"value"=>"44", "groupId"=>"BG002"}]}]}], "paramType"=>"COUNT_OF_PARTICIPANTS", "unitOfMeasure"=>"Participants"}, {"title"=>"Region of Enrollment", "classes"=>[{"title"=>"United States", "categories"=>[{"measurements"=>[{"value"=>"27", "groupId"=>"BG000"}, {"value"=>"28", "groupId"=>"BG001"}, {"value"=>"55", "groupId"=>"BG002"}]}]}], "paramType"=>"NUMBER", "unitOfMeasure"=>"participants"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-08"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2014-09", "completionDateStruct"=>{"date"=>"2002-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2014-09-03", "studyFirstSubmitDate"=>"1999-11-02", "resultsFirstSubmitDate"=>"2014-08-11", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2014-09-10", "type"=>"ESTIMATED"}, "resultsFirstSubmitQcDate"=>"2014-09-03", "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}, "resultsFirstPostDateStruct"=>{"date"=>"2014-09-10", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2002-04", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Scale for the Assessment of Negative Symptoms (SANS)", "timeFrame"=>"Baseline, Week 4, Week 8", "description"=>"The slope of SANS total score from baseline to week 8 in the treatment and placebo groups on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The slopes were obtained by plotting the group SANS total score mean for treatment vs. placebo on Baseline, Week 4, and Week 8 and performing a random slopes model."}]}, "conditionsModule"=>{"keywords"=>["Adult", "Cognition", "Cycloserine", "Dopamine", "Female", "Glutamic Acid", "Human", "Male", "Receptors, N-Methyl-D-Aspartate", "Schizophrenia", "Serotonin", "Quality of Life", "Cycloserine -- *therapeutic use", "Dopamine -- blood", "Dopamine -- cerebrospinal fluid", "Glutamic Acid -- blood", "Glutamic Acid -- cerebrospinal fluid", "Serotonin -- blood", "Serotonin -- cerebrospinal fluid"], "conditions"=>["Schizophrenia"]}, "referencesModule"=>{"references"=>[{"pmid"=>"15502972", "type"=>"RESULT", "citation"=>"Goff DC, Herz L, Posever T, Shih V, Tsai G, Henderson DC, Freudenreich O, Evins AE, Yovel I, Zhang H, Schoenfeld D. A six-month, placebo-controlled trial of D-cycloserine co-administered with conventional antipsychotics in schizophrenia patients. Psychopharmacology (Berl). 2005 Apr;179(1):144-50. doi: 10.1007/s00213-004-2032-2. Epub 2004 Oct 21."}]}, "descriptionModule"=>{"briefSummary"=>"To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment on negative symptoms, performance on neurocognitive tasks, and on markers for glutamatergic, dopaminergic and serotonergic function in serum and cerebrospinal fluid. To determine if negative symptoms and cognitive function improve over time, if these improvements meaningfully impact quality of life factors, if they correlate with markers of neuronal function, and if subpopulations can be identified according to response.\n\nDysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms, negative symptoms, and cognitive deficits of schizophrenia. Furthermore, glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity, a system central to the antipsychotic action of typical neuroleptics. It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine, a partial agonist at the glycine modulatory site of the NMDA receptor, will reduce symptoms in schizophrenia.\n\nSixty schizophrenic outpatients with prominent, primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month, fixed-dose trial. The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms (SANS). A neuropsychological battery, which emphasizes tests sensitive to prefrontal cortical function, is administered. Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine, glutamate, HVA, and 5HIAA.", "detailedDescription"=>"To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment on negative symptoms, performance on neurocognitive tasks, and on markers for glutamatergic, dopaminergic, and serotonergic function in serum and cerebrospinal fluid. To determine if negative symptoms and cognitive function improve over time, if these improvements meaningfully impact quality of life factors, if they correlate with markers of neuronal function, and if subpopulations can be identified according to response.\n\nDysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms, negative symptoms and cognitive deficits of schizophrenia. Furthermore, glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity, a system central to the antipsychotic action of typical neuroleptics. It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine, a partial agonist at the glycine modulatory site of the NMDA receptor, will reduce symptoms in schizophrenia.\n\nSixty schizophrenic outpatients with prominent, primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month, fixed-dose trial. The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms (SANS). A neuropsychological battery, which emphasizes tests sensitive to prefrontal cortical function, is administered. Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine, glutamate, HVA, and 5HIAA."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Diagnosis of Schizophrenia as per DSM IV criteria\n* Have been treated for at least 6 months with any conventional neuroleptic\n* Have prominent negative symptoms as defined by a total score of 40 or greater on the scale for the assessment of negative symptoms (SANS)\n\nExclusion Criteria:\n\n* Active alcohol or drug abuse\n* Unstable Medical Illness, seizure disorder, or other serious neurological disorder\n* Pregnant or Nursing\n* Unable to complete a cognitive battery"}, "identificationModule"=>{"nctId"=>"NCT00000371", "briefTitle"=>"Trial of D-Cycloserine in Schizophrenia", "organization"=>{"class"=>"OTHER", "fullName"=>"Massachusetts General Hospital"}, "officialTitle"=>"A Six Month, Placebo-Controlled Trial of D-Cycloserine Co-Administered With Conventional Antipsychotics in Schizophrenia Patients", "orgStudyIdInfo"=>{"id"=>"R01MH054245-01A2", "link"=>"https://reporter.nih.gov/quickSearch/R01MH054245-01A2", "type"=>"NIH"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"D-Cycloserine", "description"=>"Subjects were given 50 mg/day of D-Cycloserine for 24 weeks", "interventionNames"=>["Drug: D-cycloserine"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Participants were given 50 mg/day of Placebo for 24 weeks.", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"D-cycloserine", "type"=>"DRUG", "otherNames"=>["Cycloserine"], "description"=>"50 mg/daily by mouth", "armGroupLabels"=>["D-Cycloserine"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"50 mg/day of placebo by mouth", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"Donald Goff, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Massachusetts General Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Director of the Schizophrenia Clinical and Research Program", "investigatorFullName"=>"Donald C. Goff, MD", "investigatorAffiliation"=>"Massachusetts General Hospital"}}}}
