Antimanic Drug Use in Pregnancy (AMUP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Katherine Wisner, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00585702
First received: December 28, 2007
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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
Bipolar Disorder
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antimanic Drug Use in Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • SIGH-ADS [ Time Frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum ] [ Designated as safety issue: Yes ]
  • Mania Rating Scale [ Time Frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum ] [ Designated as safety issue: Yes ]
  • Bayley Scales of Infant Development [ Time Frame: 12, 28, 52 weeks postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight gain in pregnancy [ Time Frame: 20,30,36 weeks gestation ] [ Designated as safety issue: No ]
  • Structured Clinical Interview for DSM-IV [ Time Frame: 20 weeks gestation at enrollment ] [ Designated as safety issue: Yes ]
  • Nutritional Blood Levels [ Time Frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum ] [ Designated as safety issue: No ]
  • Maternal Functioning and Gratification [ Time Frame: 2, 12, 28, 52 weeks postpartum ] [ Designated as safety issue: No ]
  • Infant physical exam [ Time Frame: 2,12,28,52 weeks post delivery ] [ Designated as safety issue: Yes ]

Enrollment: 201
Study Start Date: August 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Pregnant women with bipolar disorder
2
Pregnant women without bipolar disorder

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585702

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Katherine L Wisner, MD MS Department of Psychiatry, School of Medicine, University of Pittsburgh
  More Information

No publications provided

Responsible Party: Katherine Wisner, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00585702     History of Changes
Other Study ID Numbers: 1 R01 MH075921, 1 R01 MH075921
Study First Received: December 28, 2007
Last Updated: September 30, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Bipolar Disorder
Pregnancy
Infant Development

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 29, 2014