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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This study has been withdrawn prior to enrollment.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

July 18, 2008
September 23, 2014
August 2005
July 2011   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00720395 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

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

Bipolar Disorder
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00720395
R01 MH085026, DATR A2-AIE
Yes
Donald Jeffery Newport, MD, Emory University
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Donald J. Newport, MD Emory University
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP