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

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Verinder Sharma
• Treatments: Quetiapine Fumarate

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