~1 spots leftby Jun 2025

Quetiapine for Postpartum Depression

Recruiting in Palo Alto (17 mi)
Overseen byVerinder Sharma, MB
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Verinder Sharma
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing quetiapine, a medication for mood disorders and sleep problems, on women with postpartum depression who don't respond well to typical antidepressants. The drug works by balancing brain chemicals to improve mood and sleep. Quetiapine has been used for treating schizophrenia, mood disorders, and sleep disturbances.

Eligibility Criteria

This trial is for outpatient women aged 18-45 who have given birth within the last 6 months and are experiencing postpartum depression, as indicated by specific scores on depression rating scales. They must be able to consent, communicate in English, and not be at high risk for suicide or currently receiving certain psychiatric treatments.

Inclusion Criteria

Within 6 months of delivery
I am able to understand and agree to the study's procedures.
I have been diagnosed with major depression or bipolar disorder related to childbirth.
+4 more

Exclusion Criteria

I am currently taking medication for my mood, depression, or sleep.
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)
+3 more

Participant Groups

The study is testing Quetiapine's safety and effectiveness in treating postpartum depression. It aims to determine how well mothers tolerate this medication, which is typically used for bipolar disorder and major depressive disorder.
1Treatment groups
Experimental Treatment
Group I: QuetiapineExperimental Treatment1 Intervention
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.

Quetiapine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Seroquel for:
  • Bipolar disorder (depressive and manic episodes)
  • Schizophrenia
  • Major depressive disorder
🇪🇺 Approved in European Union as Seroquel for:
  • Schizophrenia
  • Bipolar disorder (manic episodes)
  • Major depressive episodes in bipolar disorder

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Parkwood InstituteLondon, Canada
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Who Is Running the Clinical Trial?

Verinder SharmaLead Sponsor

References