Antimanic Drug Use in Pregnancy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00585702

Acronym

AMUP

Enrollment

201

Registered

2008-01-03

Start date

2006-08-31

Completion date

2012-03-31

Last updated

2013-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Pregnancy

Keywords

Bipolar Disorder, Pregnancy, Infant Development

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
SIGH-ADS	20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Mania Rating Scale	20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Bayley Scales of Infant Development	12, 28, 52 weeks postpartum

Secondary

Measure	Time frame
Maternal Functioning and Gratification	2, 12, 28, 52 weeks postpartum
Weight gain in pregnancy	20,30,36 weeks gestation
Infant physical exam	2,12,28,52 weeks post delivery
Structured Clinical Interview for DSM-IV	20 weeks gestation at enrollment
Nutritional Blood Levels	20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum

Countries

United States

Outcome results