Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-19 @ 3:01 AM
Study NCT ID:
NCT00350857
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2006-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Young Adult and Pediatric Bipolar Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-19', 'studyFirstSubmitDate': '2006-07-10', 'studyFirstSubmitQcDate': '2006-07-10', 'lastUpdatePostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as assessed by the occurrence of treatment emergent adverse events and evaluations of clinical laboratory values, physical examinations, vital signs and ECG data after 6 months of treatment.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': "Reduction of bipolar symptoms as assessed by the Young Mania Rating Scale (YMRS), Clinical Global Impressions Scale (CGI) and Children's Depression Rating Scale (CDRS-S) after 6 months of treatment.", 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Bipolar I Disorder']}, 'descriptionModule': {'briefSummary': 'To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Key Inclusion Criteria:\n\n 1. DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed.\n 2. A lifetime history of bipolar disorder symptoms for at least 2 months.\n 3. YMRS score greater than or equal to 16.\n 4. CGI-S score greater than or equal to 4.\n 5. Male or female outpatient aged between 10-17 years old inclusive at the time of consent.\n 6. Functioning at an age-appropriate level intellectually, as deemed by the Investigator.\n 7. The subject has no co-morbid illness that could affect efficacy, safety, or tolerability or in any way interfere with the subject's participation in the study.\n 8. Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.\n\nExclusion Criteria:\n\n* Key Exclusion Criteria:\n\n 1. Current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct.\n 2. A history of lack of therapeutic response or hypersensitivity to the study drug.\n 3. A greater than or equal to 50% reduction in YMRS between Screening and Baseline.\n 4. Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.\n 5. A history of aplastic anemia, agranulocytosis or bone marrow depression.\n 6. A history of seizure disorder, other than a single childhood febrile seizure.\n 7. A history of severe, unstable asthma.\n 8. Current hospitalization for psychiatric symptoms.\n 9. History of alcohol or other substance abuse or dependence.\n 10. Pregnant or lactating females.\n 11. Body weight less than or equal to 25 kg."}, 'identificationModule': {'nctId': 'NCT00350857', 'briefTitle': 'The Young Adult and Pediatric Bipolar Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Validus Pharmaceuticals'}, 'officialTitle': 'A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.', 'orgStudyIdInfo': {'id': 'SPD417-311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Equetro active', 'interventionNames': ['Drug: Extended-Release Carbamazepine']}], 'interventions': [{'name': 'Extended-Release Carbamazepine', 'type': 'DRUG', 'armGroupLabels': ['Equetro active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': '11 Shire Clinical Research Site', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33319', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': '17 Segal Institute for Clinical Research', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': '19 Sarkis Clinical Trials', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': '23 Shire Clinical Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': '21 Scientific Clinical Research', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '30333', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': '14 Northlake Medical Research', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '83616', 'city': 'Eagle', 'state': 'Idaho', 'country': 'United States', 'facility': '04 Mountain West Clinical Trials', 'geoPoint': {'lat': 43.69544, 'lon': -116.35401}}, {'zip': '60048', 'city': 'Libertyville', 'state': 'Illinois', 'country': 'United States', 'facility': '25 Capstone Clinical Research', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': '15 Psychiatric Associates', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': '27 Owensboro Behavioral Care', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': '05 Brentwood Research Institute', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': '13 Pharmasite Research, Inc', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': '02 Finger Lakes Clinical Research', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': '01 Nccacrf', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': '06 University of Cincinnati, College of Medicine', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': '09 Discovery and Wellness Center for Children', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': '03 IPS Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': '26 Suburban Research Associates', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': '12 Claghorn-Lesem Research Clinic', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': '07 Center for Pediatric Psychiatry', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': '24 Red Oak Psychiatry Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77566', 'city': 'Lake Jackson', 'state': 'Texas', 'country': 'United States', 'facility': '10 RID Clinical Research, Inc', 'geoPoint': {'lat': 29.03386, 'lon': -95.43439}}, {'zip': '23112', 'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'facility': '08 Dominion Clinical Research', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}, {'zip': '23452', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': '22 Brighton Research Group', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '53201', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': '20 Shire Clinical Research Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53227', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': '16 Rogers Center for Research and Training', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Validus Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}