NCT00720395

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 8, 2015

Status Verified

March 1, 2009

Enrollment Period

5.9 years

First QC Date

July 18, 2008

Last Update Submit

May 6, 2015

Conditions

Bipolar Disorder

Keywords

PsychiatryPregnancy

Outcome Measures

Primary Outcomes (1)

  • Preconception, predelivery, and postpartum predictors of postpartum bipolar disorder relapse and burden of illness

    Measured at Year 1 postpartum

Secondary Outcomes (1)

  • 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

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Active suicidality or homicidality
  • Acute psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Department of Psychaitry and Behavioral Sciences

Atlanta, Georgia, 30322, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Donald J. Newport, MD

    Emory University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 22, 2008

Study Start

August 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 8, 2015

Record last verified: 2009-03

Locations

US(1)