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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580268
First Posted: December 24, 2007
Last Update Posted: August 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Viguera, Adele, Massachusetts General Hospital
  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:


Further study details as provided by Viguera, Adele, Massachusetts General Hospital:

Primary Outcome Measures:
  • psychiatric morbidity [ Time Frame: 15 months ]

Secondary Outcome Measures:
  • obstetrical outcomes [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
serum, plasma, urine, whole blood, saliva, amniotic fluid, breast milk

Enrollment: 118
Study Start Date: August 2005
Study Completion Date: July 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
H
Pregnant women with bipolar disorder

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Viguera, Adele, MD, Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00580268     History of Changes
Obsolete Identifiers: NCT00320645
Other Study ID Numbers: 2005P001167
R01MH071762 ( U.S. NIH Grant/Contract )
First Submitted: December 20, 2007
First Posted: December 24, 2007
Last Update Posted: August 12, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders