Antimanic Drug Use in Pregnancy
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.
Status: Active, not recruiting (N/A). Started on August 1st, 2006.
Enrollment: 258 subjects
Study Type: Observational
Study Design:
- Observational Model: Cohort
- Time Perspective: Prospective
Conditions:
Interventions:
Eligibility
Inclusion Criteria for Bipolar Subjects:
Age 18 or older
Pregnant at 20 weeks or more
Women must receive OB care
English-speaking
DSM-IV diagnosis of BP, any subtype
Inclusion Criteria for non-Bipolar Control Subject:
Age 18 or older
Pregnant at 20 weeks or more
English-speaking
Women must receive OB care.
Women may have past or present subclinical Major Depressive Disorder according to the DSM-IV.
Exclusion Criteria for all:
Women must have no Active Alcohol Abuse or Dependence, Active Abuse or Dependence of Opiates, Inhalants, Amphetamines including Ecstasy or LSD, Active IV Drug Abuse, or Methadone Maintenance.
Women must not take drugs in the FDA categories D or X.
Additional Exclusion Criteria for Control Subjects:
- Women must have no lifetime history of Bipolar Disorder or antimanic drug use.
- Gender
Female
- Mininum Age
18 Years
- Maximum Age
45 Years
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: University of Pittsburgh
Authority: United States: Federal Government
Locations
-
University of Pittsburgh
Pittsburgh
Pennsylvania
15260
United States
Officials
Katherine L Wisner, MD MS (Principal Investigator, Department of Psychiatry, School of Medicine, University of Pittsburgh)
Sponsors
University of Pittsburgh (Lead Sponsor)
National Institute of Mental Health (NIMH) (Collaborator)
References
None.
Links
- Date Verified
- February 1st, 2011
- First Received
- February 18th, 2011
- Last Changed
- February 18th, 2011
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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