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

This study is currently recruiting participants.
Study NCT00720395.   Last updated on July 18, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period
Official Title  Predictors of Postpartum Relapse in Women With Bipolar Disorder
Brief Summary

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.

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 Phase
Study Type  Observational
Study Design  Cohort, Prospective
Primary Outcome Measure  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 Measure  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 ]
Condition  Bipolar Disorder
Intervention 
MEDLINE PMIDs
Links Click here for more information on this study at Emory University's Women's Mental Health Program site This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  250
Start Date  June 2008
Completion Date November 2013
Eligibility 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
Gender Female
Ages 18 Years to 45 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Bettina T. Knight, RN, BSN,CCRC     404-778-2496     bknight@emory.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00720395
Organization ID R01 MH085026
Secondary IDs †† DATR A2-AIE
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Donald J. Newport, MD     Emory University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date July 2008
First Received Date  July 18, 2008
Last Updated Date July 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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