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Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression

Information source: The Cooper Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression, Postpartum

Intervention: Sertraline (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: The Cooper Health System

Official(s) and/or principal investigator(s):
Richard L Fischer, M.D., Principal Investigator, Affiliation: Cooper Health System

Overall contact:
Richard L Fischer, M.D., Phone: 856-342-2491, Email: fischer-richard@cooperhealth.edu

Summary

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.

Clinical Details

Official title: Prophylactic Use of Immediate Postpartum Sertraline to Prevent Postpartum Depression: A Double Blind Randomized Placebo Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Development of postpartum depression up to 12 weeks following discharge from hospital

Secondary outcome:

Adverse reaction to treatment agent up to 12 weeks following discharge from hospital

Reported infant weight at 4 weeks following delivery

Perceived infant sleeping difficulty at 4 weeks postpartum

Perceived infant feeding difficulties 4 weeks postpartum

Reported infant weight at 8 weeks following delivery

Reported infant weight at 12 weeks following delivery

Perceived infant sleeping difficulty at 8 weeks postpartum

Perceived infant sleeping difficulty at 12 weeks postpartum

Perceived infant feeding difficulties 8 weeks postpartum

Perceived infant feeding difficulties 12 weeks postpartum

Detailed description: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Past history of depression or postpartum depression 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: 1. Multiple gestation 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

Locations and Contacts

Richard L Fischer, M.D., Phone: 856-342-2491, Email: fischer-richard@cooperhealth.edu

Cooper University Hospital, Camden, New Jersey 08103, United States; Recruiting
Richard L Fischer, M.D., Phone: 856-342-2491, Email: fischer-richard@cooperhealth.edu
Gunda K Simpkins, R.N., MPH, Phone: 856-968-7547, Email: Simpkins-Gunda@cooperhealth.edu
Richard L Fischer, M.D., Principal Investigator
Consuelo C Cagande, M.D., Sub-Investigator
Additional Information

Related publications:

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.

Gold LH. Postpartum disorders in primary care: diagnosis and treatment. Prim Care. 2002 Mar;29(1):27-41, vi. Review.

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. Review.

Howard LM, Hoffbrand S, Henshaw C, Boath L, Bradley E. Antidepressant prevention of postnatal depression. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004363. Review.

Malm H, Klaukka T, Neuvonen PJ. Risks associated with selective serotonin reuptake inhibitors in pregnancy. Obstet Gynecol. 2005 Dec;106(6):1289-96.

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. Review.

Payne JL. Antidepressant use in the postpartum period: practical considerations. Am J Psychiatry. 2007 Sep;164(9):1329-32. Review.

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. Review.

Safety of SSRIs in Pregnancy. Med Lett Drugs Ther. 2008 Nov 17;50(1299):89-91. Review.

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.

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.

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.

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):703-13. doi: 10.1097/AOG.0b013e3181ba0632. Review.

Starting date: July 2014
Last updated: September 5, 2014

Page last updated: August 23, 2015

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