Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00150605
Status:
COMPLETED
Last Update Posted:
2007-11-02
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2005-10'}, 'lastUpdateSubmitDate': '2007-11-01', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2007-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'YMRS Scale'}, {'measure': 'Clinical Global Impressions Scale - Bipolar Version'}, {'measure': 'HAM-D and MADRS Scales for Depression'}]}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV criteria for Bipolar I disorder\n* Screening YMRS score =\\>16\n* Women of childbearing potential agree to take adequate precautions against contraception\n* Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic\n\nExclusion Criteria:\n\n* Hospitalization required for treatment of psychiatric symptoms\n* Patients who meet DSM-IV for ultra-rapid cycling\n* History of serious suicide attempt requiring medical intervention\n* Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening'}, 'identificationModule': {'nctId': 'NCT00150605', 'briefTitle': 'Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Validus Pharmaceuticals'}, 'officialTitle': 'A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder', 'orgStudyIdInfo': {'id': 'SPD417-308'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Extended-release carbamazepine', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Validus Pharmaceuticals', 'class': 'INDUSTRY'}}}}