Bipolar Disorder (BPD) in Pregnancy: Predictors of Morbidity

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
The Cleveland Clinic
Information provided by (Responsible Party):
Donald Jeffrey Newport, Emory University
ClinicalTrials.gov Identifier:
NCT00864370
First received: February 25, 2009
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

Very little is known about the impact of pregnancy and the postpartum period on BPD. As a result, the investigators have little evidence on which to base treatment guidelines. The main goal of this study is to help fill this gap by finding the risk factors for BPD relapse during pregnancy and the postpartum period.

The risk factors that the investigators will study include:

  1. the severity of illness in the past
  2. the type and severity of both recent and past stressors
  3. any treatments received during pregnancy and the postpartum period.

Other goals of the study are:

  1. to see what effect, if any, illness or any medicines taken during pregnancy have on the baby's well-being at delivery
  2. to see how pregnancy alters the way the body clears any medicines taken for BPD
  3. to see how much of these medicines babies are exposed to during pregnancy or breast-feeding.

The investigators believe that the information gathered in this study will lead to new treatment guidelines for BPD during pregnancy and the postpartum period that will improve outcomes for pregnant women with BPD and their babies.


Condition
Pregnancy
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bipolar Disorder in Pregnancy: Predictors of Morbidity

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • To determine if psychiatric morbidity among pregnant women with BPD is greatest for those who receive suboptimal pharmacotherapy, have a more severe past illness-course, or have experienced recent psychosocial stressors. [ Time Frame: Nine months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, serum and urine samples are processed and stored at each research visit.


Enrollment: 237
Study Start Date: May 2005
Study Completion Date: June 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Despite the significant morbidity of bipolar disorder (BPD) and its high prevalence during the childbearing years, remarkably little is known about the impact of the female reproductive life cycle on BPD. Clinicians lack evidence-based guidelines for the perinatal management of BPD. The proposal addresses an understudied area with considerable public health implications for the estimated 100,000 women with BPD who conceive each year in the US.

The broad goal of this project is to delineate the clinical, psychosocial, and in particular, pharmacologic predictors of BPD recurrence during pregnancy. Preliminary findings suggest that inadequate treatment is a particularly robust predictor of prenatal BPD recurrence. Consequently, a specific emphasis will be placed on investigating the recurrence risk associated with suboptimal pharmacotherapy occurring as a result of medication discontinuation or declining drug concentrations secondary to increased prenatal clearance.

A prospective cohort design with monthly assessments will be implemented in a collaborative investigation between two of the leading perinatal psychiatry academic centers in the US with specific expertise in mood disorders research during pregnancy. The specific aims are 1) to quantify the risks for both syndromal and subsyndromal prenatal BPD illness associated with suboptimal pharmacotherapy while controlling for the severity of the previous course of illness and recent psychosocial stressors, 2) to examine the association of maternal prenatal BPD morbidity and psychotropic exposure with infant outcome at delivery thereby filling a current void and rounding out the requisite facets of the clinical risk/benefit assessment, and 3) to conduct pharmacokinetic (PK) modeling in an effort to delineate pregnancy-associated changes in drug clearance and provide initial reliable estimates of fetal drug exposure.

Study results will represent an incremental advance that: 1) elucidates risk factors for BPD morbidity during pregnancy; 2) contributes clinically relevant data to establish therapeutic guidelines for BPD during pregnancy; and 3) serve as a basis for preventive strategies aimed at optimizing maternal and infant outcome. Furthermore, the novel PK data will expand our understanding of prenatal drug metabolism, and the project will establish a cohort of children of women with BPD with detailed prospective prenatal histories.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women of child bearing potential meeting DSM-IV (Diagnostic and Statistical Manual - IV) criteria for any subtype of Bipolar Disorder

Criteria

Inclusion Criteria:

  • Medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for BPD of any subtype who are ≥ 16 weeks gestation dated by last menstrual period (LMP)
  • Able to give informed consent and comply with study procedures

Exclusion Criteria:

  • Actively suicidal or homicidal
  • Active substance use disorder within 6 months prior to enrollment
  • Positive urine drug screen
  • Hematocrit < 30
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864370

Locations
United States, Georgia
Emory University Department of Psychiatry & Behavioral Sciences
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Massachusetts General Hospital
The Cleveland Clinic
Investigators
Principal Investigator: D. Jeffrey Newport, MD Emory Unviersity
  More Information

Additional Information:
Publications:
Responsible Party: Donald Jeffrey Newport, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00864370     History of Changes
Other Study ID Numbers: IRB00046058, R01 MH071531, Bipolar Disorder in Pregnancy
Study First Received: February 25, 2009
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Psychiatry
Pregnancy
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014