NCT00580268

Brief Summary

The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

5.3 years

First QC Date

December 20, 2007

Last Update Submit

August 11, 2014

Conditions

Bipolar DisorderPsychiatric MorbidityNeonatal Outcome

Outcome Measures

Primary Outcomes (1)

  • psychiatric morbidity

    15 months

Secondary Outcomes (1)

  • obstetrical outcomes

    6 months

Study Arms (1)

H

Pregnant women with bipolar disorder

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

psychiatrists, referring obstetricians, community-based health centers, triage, and women who have previously given written permission to be contacted about research studies within the MGH Perinatal and Reproductive Psychiatry Program

You may qualify if:

  • medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period;
  • euthymic at the time of conception;
  • able to give informed consent and comply with study procedures;
  • have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45

You may not qualify if:

  • active suicidality or homicidality;
  • active substance use disorder with 6 months prior to enrollment, or
  • positive urine drug screen at enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts Geral Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, urine, whole blood, saliva, amniotic fluid, breast milk

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Adele C Viguera, MD

    MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Center for Women's Mental Health

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 24, 2007

Study Start

August 1, 2005

Primary Completion

December 1, 2010

Study Completion

July 1, 2013

Last Updated

August 12, 2014

Record last verified: 2014-08

Locations

US(2)