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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580268
• Other study ID #: 2005P001167
• Secondary ID: R01MH071762
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: August 11, 2014
• Start date: August 2005
• Est. completion date: July 2013

Study information

• Verified date: August 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT00320645

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Neonatal Outcome
• Psychiatric Morbidity

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Massachusetts Geral Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychiatric morbidity		15 months	No
Secondary	obstetrical outcomes		6 months	No

External Links

•   MGH Center for Women's Mental Health