AMUP: Antimanic Drug Use in Pregnancy

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00585702

Collaborator

National Institute of Mental Health (NIMH) (NIH)

201

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder Pregnancy

Study Design

Study Type:

Observational

Actual Enrollment :

201 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Antimanic Drug Use in Pregnancy

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
1 Pregnant women with bipolar disorder
2 Pregnant women without bipolar disorder

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15260

Sponsors and Collaborators

University of Pittsburgh
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Katherine L Wisner, MD MS, Department of Psychiatry, School of Medicine, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katherine Wisner, Professor of Psychiatry, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00585702

Other Study ID Numbers:

1R01MH075921
1R01MH075921

First Posted:

Jan 3, 2008

Last Update Posted:

Oct 7, 2013

Last Verified:

Sep 1, 2013

Keywords provided by Katherine Wisner, Professor of Psychiatry, University of Pittsburgh

Bipolar Disorder

Pregnancy

Infant Development

Additional relevant MeSH terms:

Bipolar Disorder

Study Results

No Results Posted as of Oct 7, 2013