Antimanic Drug Use in Pregnancy

Completed

• Conditions: Bipolar Disorder; Pregnancy

• Registration Number: NCT00585702
• Lead Sponsor: University of Pittsburgh

Brief Summary

The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. Participation in the study includes 7 study visits, three in pregnancy and four postpartum.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SIGH-ADS	20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Mania Rating Scale	20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Bayley Scales of Infant Development	12, 28, 52 weeks postpartum

Secondary Outcome Measures

Name	Time	Method
Nutritional Blood Levels	20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Weight gain in pregnancy	20,30,36 weeks gestation
Structured Clinical Interview for DSM-IV	20 weeks gestation at enrollment
Maternal Functioning and Gratification	2, 12, 28, 52 weeks postpartum
Infant physical exam	2,12,28,52 weeks post delivery

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States