Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression, Postpartum

Intervention / Treatment
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* Drug: Sertraline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Past history of depression or postpartum depression Singleton gestation Delivery > 34 weeks gestation No current clinical evidence of depression Able to read and understand written English language Exclusion Criteria: Multiple gestation Delivery prior to 34 weeks Delivery outside of Cooper University Hospital Major fetal anomaly or fetal demise Current use of antidepressants Evidence of active depression at antepartum evaluation Edinburgh Postpartum Depression scale of >12 prior to discharge from the hospital Maternal age < 18 years Infant in Neonatal Intensive Care Unit (NICU) at time of patient discharge from hospital Known or suspected allergy to Sertraline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sertraline<br>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper | Drug: Sertraline<br>* Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper<br>* Other names: Zoloft;|
| Placebo Comparator: Placebo<br>Identical appearing capsule daily containing color-matched cellulose only | Drug: Placebo<br>* Capsule containing cellulose powder of same color as experimental arm<br>* Other names: Cellulose powder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital | 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 0 = No postpartum depression up to 12 weeks following discharge from hospital 1 = Postpartum depression up to 12 weeks following discharge from hospital | Discharge from hospital to 12 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital | The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens | Discharge from hospital to 12 weeks postpartum | 
| Reported Infant Weight at 4 Weeks Following Delivery |  | 4 weeks postpartum | 
| Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum |  | 4 weeks postpartum | 
| Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum |  | 4 weeks postpartum | 
| Reported Infant Weight at 8 Weeks Following Delivery |  | 8 weeks postpartum | 
| Reported Infant Weight at 12 Weeks Following Delivery |  | 12 weeks postpartum | 
| Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum |  | 8 weeks postpartum | 
| Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum |  | 12 weeks postpartum | 
| Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum |  | 8 weeks postpartum | 
| Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum |  | 12 weeks postpartum |