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

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Mass General Brigham

Status

Completed

Conditions

Bipolar Disorder
Neonatal Outcome
Psychiatric Morbidity

Study type

Observational

Funder types

Other

Identifiers

NCT00580268
2005P001167
R01MH071762 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

118 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

118 participants in 1 patient group

H
Description:
Pregnant women with bipolar disorder

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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