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Completed

NCT Number: NCT00580268

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Neonatal Outcome Psychiatric Morbidity

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Emory University, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • euthymic at the time of conception;
  • able to give informed consent and comply with study procedures;
  • have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45

Exclusion criteria

  • active suicidality or homicidality;
  • active substance use disorder with 6 months prior to enrollment, or
  • positive urine drug screen at enrollment.

Treatment and study plan

Primary outcomes

  1. psychiatric morbidity

    Time frame: 15 months

Secondary outcomes

  1. obstetrical outcomes

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2013
First posted
Dec 24, 2007
Registry last updated
Aug 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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