Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00585702
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2007-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antimanic Drug Use in Pregnancy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-30', 'studyFirstSubmitDate': '2007-12-28', 'studyFirstSubmitQcDate': '2008-01-02', 'lastUpdatePostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SIGH-ADS', 'timeFrame': '20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum'}, {'measure': 'Mania Rating Scale', 'timeFrame': '20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum'}, {'measure': 'Bayley Scales of Infant Development', 'timeFrame': '12, 28, 52 weeks postpartum'}], 'secondaryOutcomes': [{'measure': 'Weight gain in pregnancy', 'timeFrame': '20,30,36 weeks gestation'}, {'measure': 'Structured Clinical Interview for DSM-IV', 'timeFrame': '20 weeks gestation at enrollment'}, {'measure': 'Nutritional Blood Levels', 'timeFrame': '20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum'}, {'measure': 'Maternal Functioning and Gratification', 'timeFrame': '2, 12, 28, 52 weeks postpartum'}, {'measure': 'Infant physical exam', 'timeFrame': '2,12,28,52 weeks post delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bipolar Disorder', 'Pregnancy', 'Infant Development'], 'conditions': ['Bipolar Disorder', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '30248632', 'type': 'DERIVED', 'citation': "Wisner KL, Sit D, O'Shea K, Bogen DL, Clark CT, Pinheiro E, Yang A, Ciolino JD. Bipolar disorder and psychotropic medication: Impact on pregnancy and neonatal outcomes. J Affect Disord. 2019 Jan 15;243:220-225. doi: 10.1016/j.jad.2018.09.045. Epub 2018 Sep 18."}, {'pmid': '28570796', 'type': 'DERIVED', 'citation': 'Yang A, Ciolino JD, Pinheiro E, Rasmussen-Torvik LJ, Sit DKY, Wisner KL. Neonatal Discontinuation Syndrome in Serotonergic Antidepressant-Exposed Neonates. J Clin Psychiatry. 2017 May;78(5):605-611. doi: 10.4088/JCP.16m11044.'}, {'pmid': '28068465', 'type': 'DERIVED', 'citation': 'Santucci AK, Singer LT, Wisniewski SR, Luther JF, Eng HF, Sit DK, Wisner KL. One-Year Developmental Outcomes for Infants of Mothers With Bipolar Disorder. J Clin Psychiatry. 2017 Sep-Oct;78(8):1083-1090. doi: 10.4088/JCP.15m10535.'}, {'pmid': '26692255', 'type': 'DERIVED', 'citation': 'Kim DR, Pinheiro E, Luther JF, Eng HF, Dills JL, Wisniewski SR, Wisner KL. Is third trimester serotonin reuptake inhibitor use associated with postpartum hemorrhage? J Psychiatr Res. 2016 Feb;73:79-85. doi: 10.1016/j.jpsychires.2015.11.005. Epub 2015 Nov 19.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. Participation in the study includes 7 study visits, three in pregnancy and four postpartum."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age 18 or older Pregnant at 20 weeks or more English-speaking DSM-IV diagnosis of BP, any subtype', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Bipolar Subjects:\n\n* Age 18 or older\n* Pregnant at 20 weeks or more\n* Women must receive OB care\n* English-speaking\n* DSM-IV diagnosis of BP, any subtype\n\nInclusion Criteria for non-Bipolar Control Subject:\n\n* Age 18 or older\n* Pregnant at 20 weeks or more\n* English-speaking\n* Women must receive OB care.\n* Women may have past or present subclinical Major Depressive Disorder according to the DSM-IV.\n\nExclusion Criteria for all:\n\n* Women must have no Active Alcohol Abuse or Dependence, Active Abuse or Dependence of Opiates, Inhalants, Amphetamines including Ecstasy or LSD, Active IV Drug Abuse, or Methadone Maintenance.\n* Women must not take drugs in the FDA categories D or X.\n\nAdditional Exclusion Criteria for Control Subjects:\n\n* Women must have no lifetime history of Bipolar Disorder or antimanic drug use.'}, 'identificationModule': {'nctId': 'NCT00585702', 'acronym': 'AMUP', 'briefTitle': 'Antimanic Drug Use in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Antimanic Drug Use in Pregnancy', 'orgStudyIdInfo': {'id': '1R01MH075921', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH075921', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01MH075921', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH075921', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Pregnant women with bipolar disorder'}, {'label': '2', 'description': 'Pregnant women without bipolar disorder'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Katherine L Wisner, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Katherine Wisner', 'investigatorAffiliation': 'University of Pittsburgh'}}}}