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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


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
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