{"protocolSection":{"identificationModule":{"nctId":"NCT01430455","orgStudyIdInfo":{"id":"6333"},"organization":{"fullName":"New York State Psychiatric Institute","class":"OTHER"},"briefTitle":"Tranylcypromine Treatment of Bipolar Depression","officialTitle":"Tranylcypromine Treatment of Bipolar Depression"},"statusModule":{"statusVerifiedDate":"2018-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2014-02","type":"ACTUAL"},"completionDateStruct":{"date":"2014-09","type":"ACTUAL"},"studyFirstSubmitDate":"2011-09-06","studyFirstSubmitQcDate":"2011-09-06","studyFirstPostDateStruct":{"date":"2011-09-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-09-25","resultsFirstSubmitQcDate":"2018-02-15","resultsFirstPostDateStruct":{"date":"2018-03-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-02-15","lastUpdatePostDateStruct":{"date":"2018-03-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"New York State Psychiatric Institute","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective treatment of bipolar depression. New treatments are needed, as there is little evidence that standard antidepressants are effective in treating this condition, and the two antipsychotic medications that have indications for bipolar depression can cause substantial side effects. This study will focus specifically on currently depressed outpatients having a bipolar history for whom at least one standard antidepressant medication was ineffective. Patients will be treated openly with tranylcypromine for 8-10 months, depending on treatment response."},"conditionsModule":{"conditions":["Bipolar Disorder I or II"],"keywords":["Major Depressive Episode","Depression NOS","Bipolar Disorder","Bipolar Disorder I","Bipolar Disorder II","Bipolar Depression","Major Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":7,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tranylcypromine","type":"EXPERIMENTAL","description":"Active, open-label tranylcypromine treatment","interventionNames":["Drug: Tranylcypromine"]}],"interventions":[{"type":"DRUG","name":"Tranylcypromine","description":"Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study","armGroupLabels":["Tranylcypromine"],"otherNames":["Parnate®"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"29 Item Hamilton Rating Scale for Depression (HamD29)","description":"29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state.","timeFrame":"Hamilton 29 score at baseline (start date of medication) and week 16"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. History of Bipolar I, II\n2. Currently depressed (major depressive episode or depression NOS)\n3. Physically healthy or physically stable (i.e.,No changes in medical interventions in past three months or likely for the next three months)\n4. On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer.\n5. Prior adequate trial on at least one antidepressant.\n6. Able to follow a tyramine-free diet\n7. Must speak English\n\nExclusion Criteria:\n\n1. Current psychosis\n2. past psychosis not occurring during an episode of mania or depression\n3. prior nonremission to tranylcypromine 60 mg/d (or greater)\n4. currently taking effective medication precluded while taking a Monoamine Oxidase Inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor)\n5. current (last six months) drug or alcohol abuse or dependence\n6. significant suicide risk\n7. significant cardiovascular risk","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"New York State Psychiatric Institute","city":"New York","state":"New York","zip":"10032","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Depression Evaluation Service","url":"http://depression-nyc.org/"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Tranylcypromine","description":"Active, open-label tranylcypromine treatment\n\nTranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"7"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Switched to follow-up phase","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Tranylcypromine","description":"Active, open-label tranylcypromine treatment\n\nTranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"7"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"7"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41","spread":"15"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"29 Item Hamilton Rating Scale for Depression (HamD29)","description":"29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state.","populationDescription":"2 patients who did not make it to week 16 (one dropped out at week 3 and one dropped out at week 9)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Hamilton Depression score","timeFrame":"Hamilton 29 score at baseline (start date of medication) and week 16","groups":[{"id":"OG000","title":"Tranylcypromine","description":"Active, open-label tranylcypromine treatment\n\nTranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"}]}],"classes":[{"title":"Baseline Score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"27.0","spread":"1.4"}]}]},{"title":"Week 16 Score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.8","spread":"2.1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Tranylcypromine","description":"Active, open-label tranylcypromine treatment\n\nTranylcypromine: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study","seriousNumAffected":0,"seriousNumAtRisk":7,"otherNumAffected":6,"otherNumAtRisk":7}],"otherEvents":[{"term":"Lightheadedness","organSystem":"Vascular disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":7}]},{"term":"Weight gain","organSystem":"Metabolism and nutrition disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Knee pain","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"increased appetite","organSystem":"Metabolism and nutrition disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Light Sensitivity","organSystem":"Eye disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"muscle tension","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"water retention","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":7}]},{"term":"postural hypotension","organSystem":"Vascular disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":7}]},{"term":"insomnia","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"constipation","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Syncope","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Leg cramps","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]},{"term":"Mild ataxia","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":7}]},{"term":"Dry Mouth","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":7}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Jonathan W. Stewart","organization":"Depression Evaluation Service (New York State Psychiatric Institute)","email":"jws6@nyspi.columbia.edu","phone":"646-774-8070"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"},{"id":"D001714","term":"Bipolar Disorder"},{"id":"D003865","term":"Depressive Disorder, Major"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D000068105","term":"Bipolar and Related Disorders"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D003866","term":"Depressive Disorder"}]},"interventionBrowseModule":{"meshes":[{"id":"D014191","term":"Tranylcypromine"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}