Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression
NCT ID: NCT02235064
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2014-07-31
2015-07-31
Brief Summary
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Detailed Description
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Patients 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.
All 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.
A 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Sertraline
Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
Sertraline
Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper
Placebo
Identical appearing capsule daily containing color-matched cellulose only
Placebo
Capsule containing cellulose powder of same color as experimental arm
Interventions
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Sertraline
Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper
Placebo
Capsule containing cellulose powder of same color as experimental arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Singleton gestation
3. Delivery \> 34 weeks gestation
4. No current clinical evidence of depression
5. Able to read and understand written English language
Exclusion Criteria
2. Delivery prior to 34 weeks
3. Delivery outside of Cooper University Hospital
4. Major fetal anomaly or fetal demise
5. Current use of antidepressants
6. Evidence of active depression at antepartum evaluation
7. Edinburgh Postpartum Depression scale of \>12 prior to discharge from the hospital
8. Maternal age \< 18 years
9. Infant in Neonatal Intensive Care Unit (NICU) at time of patient discharge from hospital
10. Known or suspected allergy to Sertraline
18 Years
FEMALE
No
Sponsors
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The Cooper Health System
OTHER
Responsible Party
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Richard Fischer MD
Professor, Department of OB/GYN, Cooper Medical School of Rowan University
Principal Investigators
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Richard L Fischer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cooper Health System
Locations
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Cooper University Hospital
Camden, New Jersey, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Safety of SSRIs in Pregnancy. Med Lett Drugs Ther. 2008 Nov 17;50(1299):89-91. No abstract available.
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.
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.
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.
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.
Other Identifiers
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CUH IRB#: 14-078
Identifier Type: -
Identifier Source: org_study_id
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