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

Verinder Sharma

Status and phase: Active, not recruiting; Phase 1

Conditions: Postpartum Depression

Treatments: Drug: Quetiapine

Study type: Interventional

Funder types: Other

Identifiers

NCT04950868

118885

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Quetiapine

Experimental group

Description:

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.

Treatment:

Drug: Quetiapine