Stop or Go? Relapse prevention training with guided tapering of antidepressants during pregnancy. A pragmatic multicenter RCT to investigate risk and benefits for mother and child.
Completed
- Conditions
- Pregnant women, depressive symptoms, anxiety, antidepressants, SSRI, tapering of medication
- Registration Number
- NL-OMON23074
- Lead Sponsor
- ErasmusMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1.Less than 16 weeks pregnant;
2.SSRI use for depressive disorder.
Exclusion Criteria
1. Insufficient proficiency in Dutch or English;
2. Multiple pregnancies (because of increased risk for adverse birth outcomes that might confound statistical analyses);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Risk (cumulative incidence) of relapse of maternal depressive disorder (as defined by the Structured Clinical Interview for DSM disorders) during pregnancy and up to 3 months postnatal.<br>
- Secondary Outcome Measures
Name Time Method