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Impact of Pregnancy and the Postpartum Period on Women With Bipolar Disorder
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), July 2007
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00320645
  Purpose

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.


Condition Phase
Bipolar Disorder
Phase I

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Convenience Sample, Retrospective/Prospective Study
Official Title: Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 200
Study Start Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320645

Contacts
Contact: Adele C. Viguera, MD, MPH 617-724-7220 aviguera@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Investigators
Principal Investigator: Adele C. Viguera, MD, MPH Massachusetts General Hospital
  More Information

Click here for the Massachusetts General Hospital Center for Women's Mental Health website  This link exits the ClinicalTrials.gov site

Study ID Numbers: R01 MH71762, DATR A2-AID, 2005-P-001167
Study First Received: April 28, 2006
Last Updated: July 19, 2007
ClinicalTrials.gov Identifier: NCT00320645  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
BPD
Pregnancy

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009