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Antimanic Drug Use in Pregnancy (AMUP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00585702
First received: December 28, 2007
Last updated: February 18, 2011
Last verified: February 2011
History of Changes
  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:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

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 ]

Estimated Enrollment: 258
Study Start Date: August 2006
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2010 (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
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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Katherine L Wisner, MD MS Department of Psychiatry, School of Medicine, University of Pittsburgh
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Katherine Wisner, MD, University of Pittsburgh Medical Center, Department of Psychiatry
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: February 18, 2011
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 May 19, 2013