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

NCT ID: NCT00580268

Last Updated: 2014-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder Psychiatric Morbidity Neonatal Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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H

Pregnant women with bipolar disorder

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Viguera, Adele

MD, Center for Women's Mental Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adele C Viguera, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Massachusetts Geral Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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http://www.womensmentalhealth.org

MGH Center for Women's Mental Health

Other Identifiers

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R01MH071762

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2005P001167

Identifier Type: -

Identifier Source: org_study_id

NCT00320645

Identifier Type: -

Identifier Source: nct_alias

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