NCT04950868Active, not recruitingPhase 1
The Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression
A Pilot Study on the Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression
Source: ClinicalTrials.gov · Last updated 5 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 11 Jun 2021
- Start date
- 18 Mar 2022
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Verinder Sharma
- Diseases
- Depression
- NCT number
- NCT04950868
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 22
- From 18 Mar 2022 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving a psychotropic drug such a mood stabilizer, an antidepressant or a sedative/hypnotic.
- Receiving psychotherapy
Other illness
- A diagnosis of schizophrenia spectrum or other psychotic disorders, obsessive-compulsive disorder, eating disorders, substance-related and addictive disorders
- Have a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine
Other
- At high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the HDRS)
- Pregnant or planning on becoming pregnant during the study
Who the study is looking for
- Outpatient woman between ages 18 - 45
- Within 6 months of delivery
- Have a DSM-5 diagnosis of MDD or BD I, BD II or other specified bipolar or related disorder with peripartum onset
- Have a score of \>18 on the 17-item Hamilton Depression Rating Scale (HDRS)
- Have a score of ≤12 Young Mania Rating Scale (YMRS) at both the screening and baseline visits
- Able to communicate in English
- Capable of providing informed consent
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parkwood Institute Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.