Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period

Predictors of Postpartum Relapse in Women With Bipolar Disorder

This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.

Study Overview

• Status: Withdrawn
• Conditions: Bipolar Disorder

Detailed Description

Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes significant changes in a person's mood and energy. The onset of bipolar disorder usually occurs during young adulthood and persists for the rest of a person's life, making women who are of childbearing age at risk for this disorder. Although overall relapse rates for pre-existing mood disorders are typically higher in women who are pregnant or recently gave birth than in other women, very little is known about the impact of pregnancy and the postpartum period on someone with bipolar disorder. The course and treatment of maternal mental illness during pregnancy and the postpartum period remains the center of much debate, particularly with respect to the use of psychotropic medications during pregnancy and breastfeeding. Identifying predictors of bipolar disorder recurrence during pregnancy and the postpartum period may help to determine which women are at highest risk and to develop new treatment guidelines. However, more information is needed to both identify predictors and develop guidelines that will improve outcomes for pregnant women with bipolar disorder and their babies. This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.

Participation in this study will last up to 6 months postpartum. Study visits will be scheduled every 4 weeks during pregnancy and every 6 weeks after delivery for up to 6 months postpartum. During study visits, data will be collected on factors that may predict bipolar disorder recurrence and overall burden of bipolar disorder illness. Specific potential factors that will be evaluated include severity of illness in the past, type and severity of both recent and past life stressors, and any treatment received during pregnancy and the postpartum period. The study will also evaluate how antidepressant medications, if taken, affect the mother and baby during pregnancy and the postpartum period. Additionally, plasma, serum, and urine samples will also be processed and stored at each study visit.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Department of Psychaitry and Behavioral Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This study will include women who are pregnant or recently gave birth and who meet DSM-IV criteria for any subtype of bipolar disorder.

Description

Inclusion Criteria:

• Medically healthy
• Meets DSM-IV criteria for bipolar disorder of any subtype
• No more than 32 weeks gestation, dated by last menstrual period

Exclusion Criteria:

• Active suicidality or homicidality
• Acute psychotic symptoms

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Women with bipolar disorder who are preconception or pregnant. Primary focus on predictors of postpartum bipolar disorder relapse and burden of illness through first six months postpartum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preconception, predelivery, and postpartum predictors of postpartum bipolar disorder relapse and burden of illness	Measured at Year 1 postpartum

Secondary Outcome Measures

Outcome Measure	Time Frame
Impact of predelivery expectations, the role of breastfeeding, and self-reported sleep disturbance in the risk for postpartum bipolar disorder relapse	Measured at Year 1 postpartum

Collaborators and Investigators

• Sponsor: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Donald J. Newport, MD, Emory University

Publications and helpful links

Helpful Links

• Click here for more information on this study at Emory University's Women's Mental Health Program site

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: July 18, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Estimate): May 8, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Pregnancy; Psychiatry
• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: R01 MH085026; DATR A2-AIE