drugset / Trial / NCT02235064
Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2014-07
- Primary completion
- 2015-07
- Completion
- 2015-07
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Background Safety of SSRIs in Pregnancy. Med Lett Drugs Ther. 2008 Nov 17;50(1299):89-91. No abstract available.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sertraline | Small molecule | 50 mg | — |