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 hospitalReported 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 = 12 on the Edinburgh Postpartum Depression scale, would then be enrolled in the
trial.
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.
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
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