Antimanic Drug Use in Pregnancy (AMUP)

September 30, 2013 updated by: Katherine Wisner, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Age 18 or older Pregnant at 20 weeks or more English-speaking DSM-IV diagnosis of BP, any subtype

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Pregnant women with bipolar disorder
2
Pregnant women without bipolar disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SIGH-ADS
Time Frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Mania Rating Scale
Time Frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Bayley Scales of Infant Development
Time Frame: 12, 28, 52 weeks postpartum
12, 28, 52 weeks postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

January 2, 2008

First Posted (Estimate)

January 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2013

Last Update Submitted That Met QC Criteria

September 30, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH075921 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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