Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity

Completed

• Conditions: Bipolar Disorder; Psychiatric Morbidity; Neonatal Outcome

• Registration Number: NCT00580268
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-24
• Primary Completion: 2010-12
• Study Completion: 2013-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-11
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

1. medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period;
2. euthymic at the time of conception;
3. able to give informed consent and comply with study procedures;
4. have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45

Exclusion Criteria

1. active suicidality or homicidality;
2. active substance use disorder with 6 months prior to enrollment, or
3. positive urine drug screen at enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
psychiatric morbidity	15 months

Secondary Outcome Measures

Name	Time	Method
obstetrical outcomes	6 months

Trial Locations

Locations (2)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Massachusetts Geral Hospital; 🇺🇸 Boston, Massachusetts, United States