Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-31 @ 8:11 PM
Study NCT ID:
NCT00720395
Status:
WITHDRAWN
Last Update Posted:
2015-05-08
First Post:
2008-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period
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_WITHOUT_DNA', 'description': 'Plasma, serum, and urine samples are processed and stored at each study visit.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn \\[Funding was never granted for this study. No participants were ever enrolled.\\]', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-06', 'studyFirstSubmitDate': '2008-07-18', 'studyFirstSubmitQcDate': '2008-07-18', 'lastUpdatePostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preconception, predelivery, and postpartum predictors of postpartum bipolar disorder relapse and burden of illness', 'timeFrame': 'Measured at Year 1 postpartum'}], 'secondaryOutcomes': [{'measure': 'Impact of predelivery expectations, the role of breastfeeding, and self-reported sleep disturbance in the risk for postpartum bipolar disorder relapse', 'timeFrame': 'Measured at Year 1 postpartum'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Psychiatry', 'Pregnancy'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://emorywomensprogram.org', 'label': "Click here for more information on this study at Emory University's Women's Mental Health Program site"}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes significant changes in a person's mood and energy. The onset of bipolar disorder usually occurs during young adulthood and persists for the rest of a person's life, making women who are of childbearing age at risk for this disorder. Although overall relapse rates for pre-existing mood disorders are typically higher in women who are pregnant or recently gave birth than in other women, very little is known about the impact of pregnancy and the postpartum period on someone with bipolar disorder. The course and treatment of maternal mental illness during pregnancy and the postpartum period remains the center of much debate, particularly with respect to the use of psychotropic medications during pregnancy and breastfeeding. Identifying predictors of bipolar disorder recurrence during pregnancy and the postpartum period may help to determine which women are at highest risk and to develop new treatment guidelines. However, more information is needed to both identify predictors and develop guidelines that will improve outcomes for pregnant women with bipolar disorder and their babies. 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.\n\nParticipation in this study will last up to 6 months postpartum. Study visits will be scheduled every 4 weeks during pregnancy and every 6 weeks after delivery for up to 6 months postpartum. During study visits, data will be collected on factors that may predict bipolar disorder recurrence and overall burden of bipolar disorder illness. Specific potential factors that will be evaluated include severity of illness in the past, type and severity of both recent and past life stressors, and any treatment received during pregnancy and the postpartum period. The study will also evaluate how antidepressant medications, if taken, affect the mother and baby during pregnancy and the postpartum period. Additionally, plasma, serum, and urine samples will also be processed and stored at each study visit."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include women who are pregnant or recently gave birth and who meet DSM-IV criteria for any subtype of bipolar disorder.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically healthy\n* Meets DSM-IV criteria for bipolar disorder of any subtype\n* No more than 32 weeks gestation, dated by last menstrual period\n\nExclusion Criteria:\n\n* Active suicidality or homicidality\n* Acute psychotic symptoms'}, 'identificationModule': {'nctId': 'NCT00720395', 'briefTitle': 'Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Mental Health (NIMH)'}, 'officialTitle': 'Predictors of Postpartum Relapse in Women With Bipolar Disorder', 'orgStudyIdInfo': {'id': 'R01 MH085026'}, 'secondaryIdInfos': [{'id': 'DATR A2-AIE'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Department of Psychaitry and Behavioral Sciences', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Donald J. Newport, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Donald Jeffery Newport, MD', 'oldOrganization': 'Emory University'}}}}