Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
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ClinicalTrials.gov Identifier: NCT00580268 |
Recruitment Status :
Completed
First Posted : December 24, 2007
Last Update Posted : August 12, 2014
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Condition or disease |
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Bipolar Disorder Psychiatric Morbidity Neonatal Outcome |
Study Type : | Observational |
Actual Enrollment : | 118 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity |
Study Start Date : | August 2005 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | July 2013 |

Group/Cohort |
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H
Pregnant women with bipolar disorder
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- psychiatric morbidity [ Time Frame: 15 months ]
- obstetrical outcomes [ Time Frame: 6 months ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- active suicidality or homicidality;
- active substance use disorder with 6 months prior to enrollment, or
- positive urine drug screen at enrollment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580268
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Massachusetts | |
Massachusetts Geral Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Adele C Viguera, MD | MGH |
Responsible Party: | Viguera, Adele, MD, Center for Women's Mental Health, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00580268 |
Obsolete Identifiers: | NCT00320645 |
Other Study ID Numbers: |
2005P001167 R01MH071762 ( U.S. NIH Grant/Contract ) |
First Posted: | December 24, 2007 Key Record Dates |
Last Update Posted: | August 12, 2014 |
Last Verified: | August 2014 |
Bipolar Disorder Bipolar and Related Disorders Mental Disorders |