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The Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression

StatusActive, Not Recruiting
PhasePhase 1
Started2022-03-18
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 5, 2025 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
Postpartum depression is a serious disorder that affects approximately 14% of women who have recently given birth. Postpartum depression is either an episode of major depressive disorder (only low periods) or bipolar disorder (periods of lows and highs). Untreated postpartum depression can negatively affect the mother, the infant and the family. Antidepressants are the most used treatments; however, for many women these drugs are not useful, resulting in a pressing need for effective treatments for postpartum depression. Lack of sleep is common after delivery and can trigger depression in some women. Quetiapine, a drug used for bipolar disorder, major depressive disorder and occasionally sleeplessness has not been well studied in postpartum depression. This study aims to find out how mothers tolerate the drug and whether it is effective for postpartum depression. Results of this study may help investigators carry out a larger study comparing quetiapine and placebo (a sugar pill) in postpartum depression.

Amendment record

Amended 4 times since 2021-06-25; most recent filed 2025-03-04. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2025-03-04
Amendment RecruitingActive, Not Recruiting Study Status, Study Design, Contacts/Locations v4
2022-03-18
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v3
2021-12-30
Amendment Study Status v2
2021-08-31
Amendment Study Status v1
2021-06-25
Original filing
Trial Details
NCT Number NCT04950868
Lead Sponsor Verinder Sharma
Conditions Postpartum Depression
Enrollment 22 participants
Start Date 2022-03-18
Primary Completion 2025-06-01 (estimated)
Study Completion 2025-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-05