Antimanic Drug Use in Pregnancy

Pregnancy Clinical Trial

— AMUP  

Official title:

Antimanic Drug Use in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585702
• Other study ID #: 1R01MH075921
• Secondary ID: 1R01MH075921
• Status: Completed
• Phase: N/A
• First received: December 28, 2007
• Last updated: September 30, 2013
• Start date: August 2006
• Est. completion date: March 2012

Study information

• Verified date: September 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Pregnancy

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIGH-ADS		20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum	Yes
Primary	Mania Rating Scale		20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum	Yes
Primary	Bayley Scales of Infant Development		12, 28, 52 weeks postpartum	No
Secondary	Weight gain in pregnancy		20,30,36 weeks gestation	No
Secondary	Structured Clinical Interview for DSM-IV		20 weeks gestation at enrollment	Yes
Secondary	Nutritional Blood Levels		20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum	No
Secondary	Maternal Functioning and Gratification		2, 12, 28, 52 weeks postpartum	No
Secondary	Infant physical exam		2,12,28,52 weeks post delivery	Yes