{"protocolSection":{"identificationModule":{"nctId":"NCT00535262","orgStudyIdInfo":{"id":"#5439"},"organization":{"fullName":"New York State Psychiatric Institute","class":"OTHER"},"briefTitle":"A Pilot Study Assessing EmSam in Bipolar Depression","officialTitle":"A Pilot Study Assessing Efficacy, Safety, and Tolerability of EmSam in Bipolar Depression"},"statusModule":{"statusVerifiedDate":"2013-05","overallStatus":"TERMINATED","whyStopped":"Current lack of medication support.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-03"},"primaryCompletionDateStruct":{"date":"2012-02","type":"ACTUAL"},"completionDateStruct":{"date":"2012-02","type":"ACTUAL"},"studyFirstSubmitDate":"2007-09-24","studyFirstSubmitQcDate":"2007-09-24","studyFirstPostDateStruct":{"date":"2007-09-26","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-10-01","resultsFirstSubmitQcDate":"2014-10-24","resultsFirstPostDateStruct":{"date":"2014-10-28","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-10-24","lastUpdatePostDateStruct":{"date":"2014-10-28","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"New York State Psychiatric Institute","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.","detailedDescription":"Most current treatments for bipolar depression have been shown to be of modest effectiveness. There is some literature which suggests that Monoamine Oxidase Inhibitors (MAOIs) have greater efficacy than tricyclic antidepressants, and that they are effective for treatment-resistant depression of all types, both unipolar and bipolar. The MAOI selegiline has demonstrated antidepressant efficacy. EmSam, a selegiline transdermal system, provides central nervous system but not intestinal/liver MAO inhibition without clinically significant increases in sensitivity to dietary tyramine. This transdermal system appears to be associated with fewer side effects and increased safety relative to oral MAOI's. This pilot study will evaluate the efficacy of EmSam in bipolar depression."},"conditionsModule":{"conditions":["Bipolar Depression"],"keywords":["Bipolar","depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":3,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"EmSam","type":"EXPERIMENTAL","description":"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.","interventionNames":["Drug: EmSam"]}],"interventions":[{"type":"DRUG","name":"EmSam","description":"Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch","armGroupLabels":["EmSam"],"otherNames":["Selegiline Transdermal"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Reduction of Depression CGI Score (<= 2)","description":"HAM-D score. Young Mania Scale Life Chart Method Patient Global Impression Symptom Checklist - 90 Quality of Life Enjoyment and Satisfaction Questionnaire\n\n0 participants analyzed due to early termination of study.","timeFrame":"8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Ages 18 - 65\n2. DSM-IV Bipolar Disorder (I, II, NOS), Depressed Phase\n3. DSM-IV Bipolar Disorder (I,II, NOS), Mixed state with adequate mood stabilization (ie, resolution of manic or hypomanic symptoms for 8 weeks with a minimum of 4 weeks on a stable dose of mood-stabilizing medication that will be continued through all phases of the study).\n4. Prior failure of or inability to tolerate at least one other antidepressant treatment\n5. Physically healthy\n6. Agrees to participate in the study\n7. HAM-D 24 \\> 10\n\nExclusion Criteria:\n\n1. Bipolar Disorder (I, II, NOS), Mixed State without adequate mood stabilization\n2. Prior significant adverse reaction to EmSam\n3. Unstable medical disorder\n4. History of epilepsy (febrile seizure o.k.)\n5. Current use of any medication that might interact with EnSam.\n6. Use within 2 weeks of other antidepressant medication (6 weeks for fluoxetine)\n7. Inability to adhere to a tyramine-free diet\n8. Recent (past 6 months) suicide attempt\n9. Serious suicidal ideation\n10. Pregnant\n11. Breast feeding\n12. Fecund, sexually active females, without adequate contraception\n13. Prior failure to respond to 2 or more adequate oral MAOI trials (2/3 PDR maximum dose, minimum 4 weeks)\n14. Non-nicotine substance abuse/dependence within the past 6 months (1 year for amphetamines/cocaine)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Deborah Deliyannides, M.D.","affiliation":"New York State Psychiatric Institute","role":"PRINCIPAL_INVESTIGATOR"}],"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":"DES official site","url":"http://www.depression-nyc.org/"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Hypomania/mania requires treatment with mood stabilizer for at least two weeks; must be anti-depressant-free for two weeks (six weeks for fluoxetine.","recruitmentDetails":"20 patients recruited from DES outpatient population with Bipolar Depression, ages 18-65.","groups":[{"id":"FG000","title":"EmSam","description":"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.\n\nEmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"3 patients were enrolled in the study. Data was collected for only two weeks before funding expired.","numSubjects":"3"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Pharmaceutical company withdrew supply of EmSam prematurely before protocol was complete.","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"}]}],"dropWithdraws":[{"type":"No funding","reasons":[{"groupId":"FG000","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Seeking pilot data","groups":[{"id":"BG000","title":"Open EmSam","description":"8-week open-label treatment with EmSam"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"}]}],"measures":[{"title":"Age, Categorical","description":"Patients with Bipolar Depression and one prior anti-depressant treatment with HAM-D (17) score \\>10 will be entered into treatment.","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":"3"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Reduction of Depression CGI Score (<= 2)","description":"HAM-D score. Young Mania Scale Life Chart Method Patient Global Impression Symptom Checklist - 90 Quality of Life Enjoyment and Satisfaction Questionnaire\n\n0 participants analyzed due to early termination of study.","reportingStatus":"POSTED","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"EmSam","description":"EmSam was administered in open-label fashion during phase I of the study during which symptoms of depression were assessed weekly. The study was terminated early so the data are not reported.\n\nEmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"EmSam","description":"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.\n\nEmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch","seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":0,"otherNumAtRisk":3}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Early termination due to lack of financial support; only 3 participants were entered into the study; no data was analyzed."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Deborah A. Deliyannides, M.D. Research Psychiatrist","organization":"Depression Evaluation Service, New York State Psychiatric Institute","email":"deliiyan@nyspi.columbia.edu","phone":"(212) 543-5734"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001714","term":"Bipolar Disorder"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D000068105","term":"Bipolar and Related Disorders"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D012642","term":"Selegiline"}],"ancestors":[{"id":"D010627","term":"Phenethylamines"},{"id":"D005021","term":"Ethylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}