Status:
WITHDRAWN
Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone
Lead Sponsor:
Verinder Sharma
Conditions:
Postpartum Depression
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
Postpartum depression is a serious illness that affects approximately 17% of women who have recently given birth. Untreated depression appears to have negative effects for both the mother and her baby...
Eligibility Criteria
Inclusion
- Healthy outpatients with a history of Major depressive disorder who are currently not on any psychotropic medications and who:
- are 18- 45 years old,
- are pregnant with gestation of 28-34 weeks,
- have been in full remission of depression for \> 2 months (as per Diagnostic and Statistical Manual-5),
- are able to communicate in English,
- are capable of providing informed consent,
- are planning to deliver at Victoria Hospital in London Ontario, and
- live in London and the surrounding area, will be enrolled.
Exclusion
- current psychiatric disorder other than generalized anxiety,
- use of psychotropic medication over the previous 2 months,
- history of bipolar disorder or psychosis,
- high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the Hamilton Depression Rating Scale-17 item \[HDRS\]),
- currently receiving psychotherapy
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05299398
Start Date
April 17 2025
End Date
August 31 2025
Last Update
April 4 2025
Active Locations (1)
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1
Parkwood Institute Mental Health Care Building
London, Ontario, Canada, N6C 0A7