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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00580268
First received: December 20, 2007
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition
Bipolar Disorder
Psychiatric Morbidity
Neonatal Outcome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • psychiatric morbidity [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • obstetrical outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, plasma, urine, whole blood, saliva, amniotic fluid, breast milk


Estimated Enrollment: 250
Study Start Date: August 2005
Estimated Study Completion Date: January 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
H
Pregnant women with bipolar disorder

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

psychiatrists, referring obstetricians, community-based health centers, triage, and women who have previously given written permission to be contacted about research studies within the MGH Perinatal and Reproductive Psychiatry Program

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580268

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts Geral Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Adele C Viguera, MD MGH
  More Information

Additional Information:
MGH Center for Women's Mental Health  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Adele C. Viguera, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00580268     History of Changes
Other Study ID Numbers: 2005P001167, R01 MH071762
Study First Received: December 20, 2007
Last Updated: July 20, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013