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Impact of Pregnancy and the Postpartum Period on Women With Bipolar Disorder

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Impact of Pregnancy and the Postpartum Period on Women With Bipolar Disorder
Official Title  Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
Brief Summary

This study will determine the risk factors for a depressive, manic, or hypomanic episode during pregnancy and the postpartum period in women with bipolar disorder.

Detailed Description

Bipolar disorder is a serious medical illness that causes shifts in a person's mood, energy, and ability to function. In women, it is particularly prevalent during the childbearing years. It is estimated that 100,000 of the women who give birth each year have bipolar disorder. Very little is known, however, about the impact of pregnancy and the postpartum period on the disorder. Evidence-based guidelines are necessary for the management of bipolar disorder during and after pregnancy. In order to develop such guidelines, more information is needed about the clinical, psychosocial, and pharmacologic predictors of a bipolar disorder recurrence during pregnancy. This study will determine the risk factors for a depressive, manic, or hypomanic episode during pregnancy and the postpartum period in women with bipolar disorder.

Women interested in participating in this observational study will first attend a study visit to determine their eligibility for participation. At this visit, a complete medical and psychiatric history will be taken, as well as blood and urine samples. The visit will last approximately 2.5 hours. If eligible, participants will attend study visits monthly during pregnancy and every 6 weeks for 6 months postpartum. At each visit, which will last 45 to 60 minutes, participants will be interviewed by a study physician and a research assistant. Additionally, participants will fill out questionnaires about Bipolar disorder symptoms and treatment, life stressors, and any medications or substances that have been taken since their last visit. Participants who are not yet pregnant at the time of study entry will attend a study visit once every 3 months until conception. Upon becoming pregnant, they will follow the same study visit schedule as participants who were pregnant at the time of study entry. No treatment will be provided in this study. Participants will continue receiving treatment from their regular physicians throughout the study.

Study Phase Phase I
Study Type  Observational
Study Design  Screening, Longitudinal, Convenience Sample, Retrospective/Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Bipolar Disorder
Intervention 
MEDLINE PMIDs
Links Click here for the Massachusetts General Hospital Center for Women's Mental Health website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  200
Start Date  August 2005
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Meets DSM-IV criteria for bipolar disorder of any type (1 or 2)
  • Currently pregnant and within 14 weeks gestation (as measured by date of last menstrual period) or planning to become pregnant
  • No mood abnormalities at the time of conception
  • Currently being treated by a psychiatrist, physician, or mental health clinician

Exclusion Criteria:

  • Actively suicidal or homicidal
  • Any serious medical illness
Gender Female
Ages 18 Years to 45 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Adele C. Viguera, MD, MPH     617-724-7220     aviguera@partners.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00320645
Organization ID R01 MH71762
Secondary IDs †† DATR A2-AID, 2005-P-001167
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Adele C. Viguera, MD, MPH     Massachusetts General Hospital    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date July 2007
First Received Date  April 28, 2006
Last Updated Date July 19, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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