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

Tracking Information

First Received Date ^ICMJE

December 28, 2007

Last Updated Date

February 18, 2011

Start Date ^ICMJE

August 2006

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00585702 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Antimanic Drug Use in Pregnancy

Official Title ^ICMJE

Antimanic Drug Use in Pregnancy

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition ^ICMJE

Bipolar Disorder
Pregnancy

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

1
Pregnant women with bipolar disorder
2
Pregnant women without bipolar disorder

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

258

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00585702

Other Study ID Numbers ^ICMJE

1 R01 MH075921, 1 R01 MH075921

Has Data Monitoring Committee

Responsible Party

Katherine Wisner, MD, University of Pittsburgh Medical Center, Department of Psychiatry

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)

Investigators ^ICMJE

Principal Investigator:

Katherine L Wisner, MD MS

Department of Psychiatry, School of Medicine, University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

February 2011

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

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