Bipolar Disorder Clinical Trial
Official title:
Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | July 2013 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | Massachusetts Geral Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | psychiatric morbidity | 15 months | No | |
Secondary | obstetrical outcomes | 6 months | No |
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