Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 1:36 PM
Study NCT ID:
NCT00047567
Status:
TERMINATED
Last Update Posted:
2015-12-14
First Post:
2002-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Adjunctive Zonisamide for Bipolar Disorder
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078305', 'term': 'Zonisamide'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-07'}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2002-07'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2002-10-08', 'studyFirstSubmitQcDate': '2002-10-09', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-10-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['ZONISAMIDE', 'BIPOLAR'], 'conditions': ['Bipolar Disorders']}, 'descriptionModule': {'briefSummary': 'To study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar I or II disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Bipolar I/II\n* Average intelligence\n* Taking at least one, but no more than two mood stabilizers'}, 'identificationModule': {'nctId': 'NCT00047567', 'briefTitle': 'Open-label Adjunctive Zonisamide for Bipolar Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elan Pharmaceuticals'}, 'orgStudyIdInfo': {'id': 'ELN-345-509'}}, 'armsInterventionsModule': {'interventions': [{'name': 'zonisamide', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elan Pharmaceuticals', 'class': 'INDUSTRY'}}}}