{"protocolSection":{"identificationModule":{"nctId":"NCT01803711","orgStudyIdInfo":{"id":"OmegaDVS"},"organization":{"fullName":"UConn Health","class":"OTHER"},"briefTitle":"Omega 3 FA Supplements as Augmentation in the Treatment of Depression","officialTitle":"A Randomized, Double-Blind Placebo-controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine for the Treatment of Major Depressive Disorder in Patients With Medical Illness."},"statusModule":{"statusVerifiedDate":"2017-11","overallStatus":"TERMINATED","whyStopped":"Lack of recruitment and no resources","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-02"},"primaryCompletionDateStruct":{"date":"2016-06","type":"ACTUAL"},"completionDateStruct":{"date":"2016-06","type":"ACTUAL"},"studyFirstSubmitDate":"2013-02-28","studyFirstSubmitQcDate":"2013-03-01","studyFirstPostDateStruct":{"date":"2013-03-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-04-13","resultsFirstSubmitQcDate":"2017-11-30","resultsFirstPostDateStruct":{"date":"2017-12-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-11-30","lastUpdatePostDateStruct":{"date":"2017-12-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"UConn Health","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety symptoms in patients with select medical conditions (cancer, cardiovascular diseases and diabetes)."},"conditionsModule":{"conditions":["Major Depression","Cancer","Diabetes","Cardiovascular Diseases"],"keywords":["Omega 3 fatty acid","Fish oil","Depression","cancer","diabetes","high blood pressure","cardiovascular"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":6,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Desvenlafaxine + Omega 3 FA supplement","type":"EXPERIMENTAL","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period","interventionNames":["Drug: Desvenlafaxine","Dietary Supplement: Omega 3 Fatty acids"]},{"label":"Desvenlafaxine + Placebo (for Omega 3 FA supplement)","type":"ACTIVE_COMPARATOR","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period","interventionNames":["Drug: Desvenlafaxine","Drug: Placebo (for Omega 3 fatty acid supplement)"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine","armGroupLabels":["Desvenlafaxine + Omega 3 FA supplement","Desvenlafaxine + Placebo (for Omega 3 FA supplement)"],"otherNames":["Pristiq"]},{"type":"DIETARY_SUPPLEMENT","name":"Omega 3 Fatty acids","armGroupLabels":["Desvenlafaxine + Omega 3 FA supplement"]},{"type":"DRUG","name":"Placebo (for Omega 3 fatty acid supplement)","armGroupLabels":["Desvenlafaxine + Placebo (for Omega 3 FA supplement)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hospital Anxiety and Depression Scale","description":"Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.","timeFrame":"12 weeks from baseline"}],"secondaryOutcomes":[{"measure":"Montgomery-Asberg Depression Rating Scale (MADRS)","timeFrame":"12 weeks from baseline"},{"measure":"Short Form Health Survey (SF-12)","timeFrame":"12 weeks from baseline"},{"measure":"Visual Analog Scale for Energy (VAS-E)","timeFrame":"12 weeks from baseline"},{"measure":"Visual Analog Scale for Pain (VAS-P)","timeFrame":"12 weeks from baseline"},{"measure":"Leeds Sleep Evaluation Questionnaire (LSEQ)","timeFrame":"12 weeks from baseline"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosed with depression and have cardiovascular disease, diabetes or cancer.\n* Able to provide written informed consent prior to initiation of any study-related procedures.\n* Able to understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Hospitalized patients or psychotherapy for depression begun within 4 weeks.\n* Patients with medically reversible causes of depression (e.g. hypothyroidism).\n* Patients with significant comorbid symptoms (e.g. pain, insomnia) that have a direct causal relation to depressive and anxiety symptoms with these comorbid symptoms dominating the clinical scenario. Patients will be enrolled in the study if these comorbid symptoms merely coexist with depressive and anxiety symptoms and are not dominating the clinical scenario as judged by the study investigator\n* Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria.\n* Patients with any clinically significant unstable or inadequately treated co-morbid medical condition which, in the opinion of the investigator, would make the patient unsuited for the study\n* Patients with currently active or with significant history of other clinically significant psychiatric disorders such as bipolar disorder, schizophrenia etc.\n* Pregnant patients, breastfeeding or those planning to become pregnant during the study.\n* Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment in the study, including known or suspect history of allergy to fish oil, fish or desvenlafaxine.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jayesh Kamath, MD PhD","affiliation":"UConn Health","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Connecticut Health Center","city":"Farmington","state":"Connecticut","zip":"06030","country":"United States","geoPoint":{"lat":41.71982,"lon":-72.83204}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"One subject who was consented did not meet the threshold for depression symptomatology during screening as determined by the Hospital Anxiety and Depression Scale.","recruitmentDetails":"A total of 30 subjects underwent phone screening. Of these, a total of 6 subjects were consented and 5 met study eligibility criteria.","groups":[{"id":"FG000","title":"Desvenlafaxine + Omega 3 FA Supplement","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period\n\nDesvenlafaxine\n\nOmega 3 Fatty acids\n\n2 subjects were randomized to this group"},{"id":"FG001","title":"Desvenlafaxine + Placebo (for Omega 3 FA Supplement)","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period\n\nDesvenlafaxine\n\nPlacebo (for Omega 3 fatty acid supplement)\n\n3 subjects were randomized to this group"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Desvenlafaxine + Omega 3 FA Supplement","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period\n\nDesvenlafaxine\n\nOmega 3 Fatty acids\n\nAge range: 53 to 66 years Gender: 1 male and 1 female"},{"id":"BG001","title":"Desvenlafaxine + Placebo (for Omega 3 FA Supplement)","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period\n\nDesvenlafaxine\n\nPlacebo (for Omega 3 fatty acid supplement) Age range: 53 to 66 years \\] Gender: 1 male and 2 females"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"White Non-Hispanic/Latino","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hospital Anxiety and Depression Scale","description":"Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.","populationDescription":"Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.","reportingStatus":"POSTED","timeFrame":"12 weeks from baseline","groups":[{"id":"OG000","title":"Desvenlafaxine + Omega 3 FA Supplement","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period\n\nDesvenlafaxine\n\nOmega 3 Fatty acids"},{"id":"OG001","title":"Desvenlafaxine + Placebo (for Omega 3 FA Supplement)","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period\n\nDesvenlafaxine\n\nPlacebo (for Omega 3 fatty acid supplement)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Montgomery-Asberg Depression Rating Scale (MADRS)","populationDescription":"Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.","reportingStatus":"POSTED","timeFrame":"12 weeks from baseline","groups":[{"id":"OG000","title":"Desvenlafaxine + Omega 3 FA Supplement","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period\n\nDesvenlafaxine\n\nOmega 3 Fatty acids\n\n2 subjects were randomized to this group"},{"id":"OG001","title":"Desvenlafaxine + Placebo (for Omega 3 FA Supplement)","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period\n\nDesvenlafaxine\n\nPlacebo (for Omega 3 fatty acid supplement)\n\n3 subjects were randomized to this group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Short Form Health Survey (SF-12)","populationDescription":"Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.","reportingStatus":"POSTED","timeFrame":"12 weeks from baseline","groups":[{"id":"OG000","title":"Desvenlafaxine + Omega 3 FA Supplement","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period\n\nDesvenlafaxine\n\nOmega 3 Fatty acids\n\n2 subjects were randomized to this group"},{"id":"OG001","title":"Desvenlafaxine + Placebo (for Omega 3 FA Supplement)","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period\n\nDesvenlafaxine\n\nPlacebo (for Omega 3 fatty acid supplement)\n\n3 subjects were randomized to this group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Visual Analog Scale for Energy (VAS-E)","populationDescription":"Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.","reportingStatus":"POSTED","timeFrame":"12 weeks from baseline","groups":[{"id":"OG000","title":"Desvenlafaxine + Omega 3 FA Supplement","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period\n\nDesvenlafaxine\n\nOmega 3 Fatty acids\n\n2 subjects were randomized to this group"},{"id":"OG001","title":"Desvenlafaxine + Placebo (for Omega 3 FA Supplement)","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period\n\nDesvenlafaxine\n\nPlacebo (for Omega 3 fatty acid supplement)\n\n3 subjects were randomized to this group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Visual Analog Scale for Pain (VAS-P)","populationDescription":"Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.","reportingStatus":"POSTED","timeFrame":"12 weeks from baseline","groups":[{"id":"OG000","title":"Desvenlafaxine + Omega 3 FA Supplement","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period\n\nDesvenlafaxine\n\nOmega 3 Fatty acids\n\n2 subjects were randomized to this group"},{"id":"OG001","title":"Desvenlafaxine + Placebo (for Omega 3 FA Supplement)","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period\n\nDesvenlafaxine\n\nPlacebo (for Omega 3 fatty acid supplement)\n\n3 subjects were randomized to this group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Leeds Sleep Evaluation Questionnaire (LSEQ)","populationDescription":"Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.","reportingStatus":"POSTED","timeFrame":"12 weeks from baseline","groups":[{"id":"OG000","title":"Desvenlafaxine + Omega 3 FA Supplement","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period\n\nDesvenlafaxine\n\nOmega 3 Fatty acids\n\n2 subjects were randomized to this group"},{"id":"OG001","title":"Desvenlafaxine + Placebo (for Omega 3 FA Supplement)","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period\n\nDesvenlafaxine\n\nPlacebo (for Omega 3 fatty acid supplement)\n\n3 subjects were randomized to this group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Desvenlafaxine + Omega 3 FA Supplement","description":"Desvenlafaxine 50mg/day \\& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period\n\nDesvenlafaxine\n\nOmega 3 Fatty acids\n\n2 subjects were randomized to this group","deathsNumAffected":0,"deathsNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"otherNumAffected":1,"otherNumAtRisk":2},{"id":"EG001","title":"Desvenlafaxine + Placebo (for Omega 3 FA Supplement)","description":"Desvenlafaxine 50mg/day \\& Placebo (for Omega 3 FA supplement) over a 12 week period\n\nDesvenlafaxine\n\nPlacebo (for Omega 3 fatty acid supplement)\n\n3 subjects were randomized to this group","deathsNumAffected":0,"deathsNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":1,"otherNumAtRisk":3}],"otherEvents":[{"term":"diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Stomach upsets","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":2},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":3}]},{"term":"Memory problems","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Memory problems","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":2},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":3}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Due to very low enrollment in both arms, only descriptive analyses was completed for both arms"},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Jayesh Kamath MD PhD","organization":"UConn Health Center","email":"jkamath@uchc.edu","phone":"8606796727"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D009369","term":"Neoplasms"},{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D003863","term":"Depression"},{"id":"D006973","term":"Hypertension"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D014652","term":"Vascular Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069468","term":"Desvenlafaxine Succinate"},{"id":"D015525","term":"Fatty Acids, Omega-3"}],"ancestors":[{"id":"D003511","term":"Cyclohexanols"},{"id":"D000441","term":"Hexanols"},{"id":"D005233","term":"Fatty Alcohols"},{"id":"D000438","term":"Alcohols"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D003510","term":"Cyclohexanes"},{"id":"D003516","term":"Cycloparaffins"},{"id":"D006840","term":"Hydrocarbons, Alicyclic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D010636","term":"Phenols"},{"id":"D001555","term":"Benzene Derivatives"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D008055","term":"Lipids"},{"id":"D004042","term":"Dietary Fats, Unsaturated"},{"id":"D004041","term":"Dietary Fats"},{"id":"D005223","term":"Fats"},{"id":"D005231","term":"Fatty Acids, Unsaturated"},{"id":"D005227","term":"Fatty Acids"},{"id":"D005395","term":"Fish Oils"},{"id":"D009821","term":"Oils"}]}},"hasResults":true}