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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00720395
First received: July 18, 2008
Last updated: September 23, 2014
Last verified: March 2009
  Purpose

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.


Condition
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Postpartum Relapse in Women With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Preconception, predelivery, and postpartum predictors of postpartum bipolar disorder relapse and burden of illness [ Time Frame: Measured at Year 1 postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of predelivery expectations, the role of breastfeeding, and self-reported sleep disturbance in the risk for postpartum bipolar disorder relapse [ Time Frame: Measured at Year 1 postpartum ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Enrollment: 0
Study Start Date: August 2005
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  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

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

Criteria

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
  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: NCT00720395

Locations
United States, Georgia
Emory University Department of Psychaitry and Behavioral Sciences
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Investigators
Principal Investigator: Donald J. Newport, MD Emory University
  More Information

No publications provided

Responsible Party: Donald Jeffery Newport, MD, Emory University
ClinicalTrials.gov Identifier: NCT00720395     History of Changes
Other Study ID Numbers: R01 MH085026, DATR A2-AIE
Study First Received: July 18, 2008
Last Updated: September 23, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Psychiatry
Pregnancy

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

ClinicalTrials.gov processed this record on November 27, 2014