Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT00580268
Status:
COMPLETED
Last Update Posted:
2014-08-12
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma, urine, whole blood, saliva, amniotic fluid, breast milk'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2007-12-20', 'lastUpdatePostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'psychiatric morbidity', 'timeFrame': '15 months'}], 'secondaryOutcomes': [{'measure': 'obstetrical outcomes', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bipolar Disorder', 'Psychiatric Morbidity', 'Neonatal Outcome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.womensmentalhealth.org', 'label': "MGH Center for Women's Mental Health"}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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;\n2. euthymic at the time of conception;\n3. able to give informed consent and comply with study procedures;\n4. have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45\n\nExclusion Criteria:\n\n1. active suicidality or homicidality;\n2. active substance use disorder with 6 months prior to enrollment, or\n3. positive urine drug screen at enrollment.'}, 'identificationModule': {'nctId': 'NCT00580268', 'briefTitle': 'Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity', 'nctIdAliases': ['NCT00320645'], 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity', 'orgStudyIdInfo': {'id': '2005P001167'}, 'secondaryIdInfos': [{'id': 'R01MH071762', 'link': 'https://reporter.nih.gov/quickSearch/R01MH071762', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'H', 'description': 'Pregnant women with bipolar disorder'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Geral Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Adele C Viguera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MGH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "MD, Center for Women's Mental Health", 'investigatorFullName': 'Viguera, Adele', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}