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

NCT ID: NCT04950868

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2025-06-01

Brief Summary

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.

Conditions

Postpartum Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quetiapine

They will initially be given 25 mg of quetiapine per day. The dose may be increased by 25-50 mg per week, to a maximum dose of 150 mg per day by week 6 of the study.

Group Type: EXPERIMENTAL

Quetiapine

Intervention Type: DRUG

They will initially be given 25 mg of quetiapine per day. The dose may be increased by 25-50 mg per week, to a maximum dose of 150 mg per day by week 6 of the study.

Interventions

Quetiapine

They will initially be given 25 mg of quetiapine per day. The dose may be increased by 25-50 mg per week, to a maximum dose of 150 mg per day by week 6 of the study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• A diagnosis of schizophrenia spectrum or other psychotic disorders, obsessive-compulsive disorder, eating disorders, substance-related and addictive disorders
• At high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the HDRS)
• Receiving a psychotropic drug such a mood stabilizer, an antidepressant or a sedative/hypnotic.
• Receiving psychotherapy
• Have a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine
• Pregnant or planning on becoming pregnant during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Verinder Sharma

OTHER

Sponsor Role: lead

Responsible Party

Verinder Sharma

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Verinder Sharma, MB

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

Parkwood Institute

London, Ontario, Canada

Countries

Canada

Other Identifiers

118885

Identifier Type: -

Identifier Source: org_study_id