Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression

NCT02235064 | Terminated Results

• 1 other identifier: CUH IRB#: 14-078
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital

  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

Study Arms (2)

Sertraline

EXPERIMENTAL

Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper

Drug: Sertraline

Placebo

PLACEBO COMPARATOR

Identical appearing capsule daily containing color-matched cellulose only

Drug: Placebo

Interventions

Sertraline DRUG

Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper

Also known as: Zoloft

Sertraline

Placebo DRUG

Capsule containing cellulose powder of same color as experimental arm

Also known as: Cellulose powder

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Related Publications (13)

• 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: 16467545 BACKGROUND

• 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: 11856657 BACKGROUND

• 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: 18378767 BACKGROUND

• 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: 15846711 BACKGROUND

• 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: 16319254 BACKGROUND

• 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: 15900008 BACKGROUND

• 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: 17728416 BACKGROUND

• 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: 19318144 BACKGROUND

• Safety of SSRIs in Pregnancy. Med Lett Drugs Ther. 2008 Nov 17;50(1299):89-91. No abstract available.

  PMID: 19008787 BACKGROUND

• 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: 15705457 BACKGROUND

• 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: 15229064 BACKGROUND

• 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: 11247106 BACKGROUND

• 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.

  PMID: 19701065 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Richard L Fischer
• Organization: Cooper University Health System

fischer-richard@cooperhealth.edu

856-342-2491

Study Officials

• Richard L Fischer, M.D.

  Cooper Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of OB/GYN, Cooper Medical School of Rowan University

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: September 9, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 29, 2018
• Results First Posted: April 10, 2017

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)