{"protocolSection":{"identificationModule":{"nctId":"NCT02235064","orgStudyIdInfo":{"id":"CUH IRB#: 14-078"},"organization":{"fullName":"The Cooper Health System","class":"OTHER"},"briefTitle":"Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression","officialTitle":"Prophylactic Use of Immediate Postpartum Sertraline to Prevent Postpartum Depression: A Double Blind Randomized Placebo Controlled Trial"},"statusModule":{"statusVerifiedDate":"2018-02","overallStatus":"TERMINATED","whyStopped":"Low recruitment, completion of funding cycle","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-07"},"primaryCompletionDateStruct":{"date":"2015-07","type":"ACTUAL"},"completionDateStruct":{"date":"2015-07","type":"ACTUAL"},"studyFirstSubmitDate":"2014-08-08","studyFirstSubmitQcDate":"2014-09-05","studyFirstPostDateStruct":{"date":"2014-09-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-02-24","resultsFirstSubmitQcDate":"2017-02-24","resultsFirstPostDateStruct":{"date":"2017-04-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-02-27","lastUpdatePostDateStruct":{"date":"2018-03-29","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Richard Fischer MD","investigatorTitle":"Professor, Department of OB/GYN, Cooper Medical School of Rowan University","investigatorAffiliation":"The Cooper Health System"},"leadSponsor":{"name":"The Cooper Health System","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this project is to assess the effectiveness of preventative antidepressants immediately following delivery on postpartum depression rates in women at high risk due to prior history of depression or postpartum depression.","detailedDescription":"Eligible women for our study would be identified antepartum from our three obstetrical groups delivering at Cooper University Hospital: Cooper Faculty Group, Women's Care Center, and CamCare. Potentially eligible women would be referred to the study coordinator or principal investigator to discuss the nature of the study. Those women who agreed to the trial would be further screened with a baseline structured psychiatric evaluation in the third trimester of the pregnancy to rule-out current depressive illness. If there was no evidence of depression at the antepartum evaluation, patients delivering a liveborn singleton fetus at 34 0/7 weeks or greater would be re-evaluated prior to discharge and, if scoring \\</= 12 on the Edinburgh Postpartum Depression scale, would then be enrolled in the trial.\n\nPatients would be assigned to either sertraline 50 mg daily or identical appearing placebo for 12 weeks. Group allocation would be determined by restricted-randomization technique with variable block length, with the sequence generated by someone not associated with participant assignment. Assignment would be kept in sequentially numbered, opaque, sealed envelopes (SNOSE) in the pharmacy, which would dispense the medication (or placebo). Patients would be given a 30 day supply on the day of discharge, with refills provided by the study coordinator (through the pharmacy)for 12 weeks and a four-day supply of 25 mg Sertraline or placebo at the end of 12 weeks as a taper. Patients would also undergo follow-up blinded structured psychiatric evaluations at 4 weeks, 8 weeks, and 12 weeks to assess for adverse reaction to the assigned treatment agent, and for administration of questionnaires/evaluation to assess for development of depression. Any patient with recognized clinical depression would immediately be removed from further active participation in the study and referred to our Cooper Psychiatry department or outside psychiatrist for ongoing evaluation and treatment. Medication received (Sertraline or Placebo) would necessarily be revealed to Psych only for purposes of guiding appropriate further treatment.\n\nAll women randomized would be analyzed according to group assignment (intent-to-treat). Demographic information, including patient age, race/ethnicity, gravidity, parity, gestational age at delivery, infant birth weight, as well as infant weights from standard Pediatric visits (obtained verbally from the mother)would be recorded and compared using the Student t-test for normally distributed continuous data, Mann-Whitney U for non-normative continuous data, and the Chi Square test or Fisher Exact test for categorical data.\n\nA sample size calculation was performed. Based on an anticipated rate of postpartum depression (PPD) of 30% in the placebo group, we would need 62 subjects in each group to detect a reduction in PPD to 10% in the sertraline group, with a power of .8 and a Type I error of .05. Based on the 2200 deliveries occurring annually at Cooper University Hospital, we anticipate that it would take 2-3 years to recruit 124 subjects into this study."},"conditionsModule":{"conditions":["Depression, Postpartum"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":2,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Sertraline","type":"EXPERIMENTAL","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper","interventionNames":["Drug: Sertraline"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Identical appearing capsule daily containing color-matched cellulose only","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Sertraline","description":"Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper","armGroupLabels":["Sertraline"],"otherNames":["Zoloft"]},{"type":"DRUG","name":"Placebo","description":"Capsule containing cellulose powder of same color as experimental arm","armGroupLabels":["Placebo"],"otherNames":["Cellulose powder"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital","description":"Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment\n\n0 = No postpartum depression up to 12 weeks following discharge from hospital\n\n1 = Postpartum depression up to 12 weeks following discharge from hospital","timeFrame":"Discharge from hospital to 12 weeks postpartum"}],"secondaryOutcomes":[{"measure":"Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital","description":"The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens","timeFrame":"Discharge from hospital to 12 weeks postpartum"},{"measure":"Reported Infant Weight at 4 Weeks Following Delivery","timeFrame":"4 weeks postpartum"},{"measure":"Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum","timeFrame":"4 weeks postpartum"},{"measure":"Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum","timeFrame":"4 weeks postpartum"},{"measure":"Reported Infant Weight at 8 Weeks Following Delivery","timeFrame":"8 weeks postpartum"},{"measure":"Reported Infant Weight at 12 Weeks Following Delivery","timeFrame":"12 weeks postpartum"},{"measure":"Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum","timeFrame":"8 weeks postpartum"},{"measure":"Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum","timeFrame":"12 weeks postpartum"},{"measure":"Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum","timeFrame":"8 weeks postpartum"},{"measure":"Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum","timeFrame":"12 weeks postpartum"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Past history of depression or postpartum depression\n2. Singleton gestation\n3. Delivery \\> 34 weeks gestation\n4. No current clinical evidence of depression\n5. Able to read and understand written English language\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Delivery prior to 34 weeks\n3. Delivery outside of Cooper University Hospital\n4. Major fetal anomaly or fetal demise\n5. Current use of antidepressants\n6. Evidence of active depression at antepartum evaluation\n7. Edinburgh Postpartum Depression scale of \\>12 prior to discharge from the hospital\n8. Maternal age \\< 18 years\n9. Infant in Neonatal Intensive Care Unit (NICU) at time of patient discharge from hospital\n10. Known or suspected allergy to Sertraline","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Richard L Fischer, M.D.","affiliation":"Cooper Health System","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Cooper University Hospital","city":"Camden","state":"New Jersey","zip":"08103","country":"United States","geoPoint":{"lat":39.92595,"lon":-75.11962}}]},"referencesModule":{"references":[{"pmid":"16467545","type":"BACKGROUND","citation":"Chambers CD, Hernandez-Diaz S, Van Marter LJ, Werler MM, Louik C, Jones KL, Mitchell AA. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med. 2006 Feb 9;354(6):579-87. doi: 10.1056/NEJMoa052744."},{"pmid":"11856657","type":"BACKGROUND","citation":"Gold LH. Postpartum disorders in primary care: diagnosis and treatment. Prim Care. 2002 Mar;29(1):27-41, vi. doi: 10.1016/s0095-4543(03)00072-1."},{"pmid":"18378767","type":"BACKGROUND","citation":"ACOG Committee on Practice Bulletins--Obstetrics. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87, November 2007). Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2008 Apr;111(4):1001-20. doi: 10.1097/AOG.0b013e31816fd910. No abstract available."},{"pmid":"15846711","type":"BACKGROUND","citation":"Howard LM, Hoffbrand S, Henshaw C, Boath L, Bradley E. Antidepressant prevention of postnatal depression. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004363. doi: 10.1002/14651858.CD004363.pub2."},{"pmid":"16319254","type":"BACKGROUND","citation":"Malm H, Klaukka T, Neuvonen PJ. Risks associated with selective serotonin reuptake inhibitors in pregnancy. Obstet Gynecol. 2005 Dec;106(6):1289-96. doi: 10.1097/01.AOG.0000187302.61812.53."},{"pmid":"15900008","type":"BACKGROUND","citation":"Moses-Kolko EL, Bogen D, Perel J, Bregar A, Uhl K, Levin B, Wisner KL. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications. JAMA. 2005 May 18;293(19):2372-83. doi: 10.1001/jama.293.19.2372."},{"pmid":"17728416","type":"BACKGROUND","citation":"Payne JL. Antidepressant use in the postpartum period: practical considerations. Am J Psychiatry. 2007 Sep;164(9):1329-32. doi: 10.1176/appi.ajp.2007.07030390. No abstract available."},{"pmid":"19318144","type":"BACKGROUND","citation":"Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033."},{"pmid":"19008787","type":"BACKGROUND","citation":"Safety of SSRIs in Pregnancy. Med Lett Drugs Ther. 2008 Nov 17;50(1299):89-91. No abstract available."},{"pmid":"15705457","type":"BACKGROUND","citation":"Sanz EJ, De-las-Cuevas C, Kiuru A, Bate A, Edwards R. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet. 2005 Feb 5-11;365(9458):482-7. doi: 10.1016/S0140-6736(05)17865-9."},{"pmid":"15229064","type":"BACKGROUND","citation":"Wisner KL, Perel JM, Peindl KS, Hanusa BH, Piontek CM, Findling RL. Prevention of postpartum depression: a pilot randomized clinical trial. Am J Psychiatry. 2004 Jul;161(7):1290-2. doi: 10.1176/appi.ajp.161.7.1290."},{"pmid":"11247106","type":"BACKGROUND","citation":"Wisner KL, Perel JM, Peindl KS, Hanusa BH, Findling RL, Rapport D. Prevention of recurrent postpartum depression: a randomized clinical trial. J Clin Psychiatry. 2001 Feb;62(2):82-6. doi: 10.4088/jcp.v62n0202."},{"pmid":"19701065","type":"BACKGROUND","citation":"Yonkers KA, Wisner KL, Stewart DE, Oberlander TF, Dell DL, Stotland N, Ramin S, Chaudron L, Lockwood C. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Obstet Gynecol. 2009 Sep;114(3):703-713. doi: 10.1097/AOG.0b013e3181ba0632."}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Only aggregate data to be reported"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper\n\nSertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"},{"id":"FG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose only\n\nPlacebo: Capsule containing cellulose powder of same color as experimental arm"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper\n\nSertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"},{"id":"BG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose only\n\nPlacebo: Capsule containing cellulose powder of same color as experimental arm"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}],"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":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33","lowerLimit":"33","upperLimit":"33"},{"groupId":"BG001","value":"30","lowerLimit":"30","upperLimit":"30"},{"groupId":"BG002","value":"31.5","lowerLimit":"30","upperLimit":"33"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital","description":"Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment\n\n0 = No postpartum depression up to 12 weeks following discharge from hospital\n\n1 = Postpartum depression up to 12 weeks following discharge from hospital","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Discharge from hospital to 12 weeks postpartum","groups":[{"id":"OG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper\n\nSertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"},{"id":"OG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose only\n\nPlacebo: Capsule containing cellulose powder of same color as experimental arm"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital","description":"The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Discharge from hospital to 12 weeks postpartum","groups":[{"id":"OG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper"},{"id":"OG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose only"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"SECONDARY","title":"Reported Infant Weight at 4 Weeks Following Delivery","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Full Range","unitOfMeasure":"Grams","timeFrame":"4 weeks postpartum","groups":[{"id":"OG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper"},{"id":"OG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose only"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3033","lowerLimit":"3033","upperLimit":"3033"},{"groupId":"OG001","value":"2750","lowerLimit":"2750","upperLimit":"2750"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"4 weeks postpartum","groups":[{"id":"OG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper"},{"id":"OG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose only"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"4 weeks postpartum","groups":[{"id":"OG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper"},{"id":"OG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose only"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Reported Infant Weight at 8 Weeks Following Delivery","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Full Range","unitOfMeasure":"Grams","timeFrame":"8 weeks postpartum","groups":[{"id":"OG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper"},{"id":"OG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose 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only"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5301","lowerLimit":"5301","upperLimit":"5301"},{"groupId":"OG001","value":"4734","lowerLimit":"4734","upperLimit":"4734"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"8 weeks postpartum","groups":[{"id":"OG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper"},{"id":"OG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose 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only"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"12 weeks postpartum","groups":[{"id":"OG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper"},{"id":"OG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose only"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"12 weeks","eventGroups":[{"id":"EG000","title":"Sertraline","description":"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper\n\nSertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper","deathsNumAffected":0,"deathsNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"otherNumAffected":0,"otherNumAtRisk":1},{"id":"EG001","title":"Placebo","description":"Identical appearing capsule daily containing color-matched cellulose only\n\nPlacebo: Capsule containing cellulose powder of same color as experimental arm","deathsNumAffected":0,"deathsNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"otherNumAffected":1,"otherNumAtRisk":1}],"otherEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":1},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Richard L Fischer","organization":"Cooper University Health System","email":"fischer-richard@cooperhealth.edu","phone":"856-342-2491"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D019052","term":"Depression, Postpartum"}],"ancestors":[{"id":"D011644","term":"Puerperal Disorders"},{"id":"D011248","term":"Pregnancy Complications"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D020280","term":"Sertraline"}],"ancestors":[{"id":"D015057","term":"1-Naphthylamine"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009281","term":"Naphthalenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D011083","term":"Polycyclic Compounds"}]}},"hasResults":true}