Status:
COMPLETED
Patient Decision Aid for Antidepressant Use in Pregnancy
Lead Sponsor:
Women's College Hospital
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Conditions:
Pregnancy
Depression
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this pilot study is to examine the feasibility of conducting a multi-site randomized controlled trial whose aim will be to evaluate the effectiveness of a Patient Decision Aid (PDA) for...
Detailed Description
Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pre...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Are females aged \>18 years old, and
- Are either planning a pregnancy OR are \<30 weeks gestation at enrollment, and
- Have been offered to start or continue SSRI or SNRI anti-depressant medication as a treatment option for depression by their clinical provider at one of the study sites, and
- Have moderate-to-high decisional conflict (score of \>25 on the Decisional Conflict Scale)
- Exclusion criteria:
- Have had alcohol or substance abuse or dependence in the previous 12 months, or
- Have active suicidal ideation or psychosis, or
- Are incapable of consenting to participation, or
- Have any major obstetrical complications or fetal cardiac anomaly in the current or in a past pregnancy (as this changes the risk/benefit ratio discussion in regards to antidepressant use), or
- Are unable to read or unable to speak or understand English and do not have someone that can read the PDA to them, or
- Have a visual impairment that would prevent them from being able to view the website.
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02308592
Start Date
January 1 2015
End Date
April 1 2017
Last Update
May 12 2017
Active Locations (1)
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1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2