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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 28, 2006 | ||||||||
| Last Updated Date | August 3, 2009 | ||||||||
| Start Date ICMJE | August 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00320645 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Impact of Pregnancy and the Postpartum Period on Women With Bipolar Disorder | ||||||||
| Official Title ICMJE | Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity | ||||||||
| Brief Summary | This study will determine the risk factors for a depressive, manic, or hypomanic episode during pregnancy and the postpartum period in women with bipolar disorder. |
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| Detailed Description | Bipolar disorder is a serious medical illness that causes shifts in a person's mood, energy, and ability to function. In women, it is particularly prevalent during the childbearing years. It is estimated that 100,000 of the women who give birth each year have bipolar disorder. Very little is known, however, about the impact of pregnancy and the postpartum period on the disorder. Evidence-based guidelines are necessary for the management of bipolar disorder during and after pregnancy. In order to develop such guidelines, more information is needed about the clinical, psychosocial, and pharmacologic predictors of a bipolar disorder recurrence during pregnancy. This study will determine the risk factors for a depressive, manic, or hypomanic episode during pregnancy and the postpartum period in women with bipolar disorder. Women interested in participating in this observational study will first attend a study visit to determine their eligibility for participation. At this visit, a complete medical and psychiatric history will be taken, as well as blood and urine samples. The visit will last approximately 2.5 hours. If eligible, participants will attend study visits monthly during pregnancy and every 6 weeks for 6 months postpartum. At each visit, which will last 45 to 60 minutes, participants will be interviewed by a study physician and a research assistant. Additionally, participants will fill out questionnaires about Bipolar disorder symptoms and treatment, life stressors, and any medications or substances that have been taken since their last visit. Participants who are not yet pregnant at the time of study entry will attend a study visit once every 3 months until conception. Upon becoming pregnant, they will follow the same study visit schedule as participants who were pregnant at the time of study entry. No treatment will be provided in this study. Participants will continue receiving treatment from their regular physicians throughout the study. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Other | ||||||||
| Condition ICMJE | Bipolar Disorder | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00320645 | ||||||||
| Responsible Party | Adele C. Viguera, MD, MPH, Massachusetts General Hospital | ||||||||
| Study ID Numbers ICMJE | R01 MH071762, DATR A2-AID, 2005-P-001167 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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