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

December 28, 2007
September 30, 2013
August 2006
March 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00585702 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Antimanic Drug Use in Pregnancy
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Bipolar Disorder
  • Pregnancy
Not Provided
  • 1
    Pregnant women with bipolar disorder
  • 2
    Pregnant women without bipolar disorder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585702
1 R01 MH075921, 1 R01 MH075921
No
Katherine Wisner, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Katherine L Wisner, MD MS Department of Psychiatry, School of Medicine, University of Pittsburgh
University of Pittsburgh
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP