Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00035802
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2002-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000341', 'term': 'Affective Disorders, Psychotic'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-23', 'studyFirstSubmitDate': '2002-05-06', 'studyFirstSubmitQcDate': '2002-05-06', 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in total Young Mania Rating Scale (YMRS) score', 'timeFrame': 'Baseline to Day 28 (or last available observation prior to Day 28).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Clinical Global Impression Scale (CGI-S) score', 'timeFrame': 'Baseline to Day 28 (or last available observation prior to Day 28).'}, {'measure': "Change from baseline in Children's Global Assessment Scale (C-GAS) score", 'timeFrame': 'Baseline to Day 28 (or last available observation prior to Day 28).'}, {'measure': 'The number of patients continuing to meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for manic or mixed episodes of Bipolar I Disorder', 'timeFrame': 'Day 28 (or last available observation prior to Day 28)'}]}, 'conditionsModule': {'keywords': ['Bipolar', 'Mania', 'Pediatric', 'Children', 'Adolescent', 'Topiramate', 'Anticonvulsants', 'Central Nervous System Agents', 'Protective Agents', 'Neuroprotectiive Agents'], 'conditions': ['Bipolar Disorder', 'Affective Disorders, Psychotic', 'Mood Disorders', 'Mental Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.', 'detailedDescription': 'This is a 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label (OL) extension for qualified patients following completion of the study. On Days 1-28 patients will receive placebo or topiramate 2x/day by mouth except for the 1st and last doses which will be a single evening dose and a single morning dose, respectively. Study drug will be titrated in 100-mg increments to 400 mg/day and patients maintained on a stable dose through Day 28. During the OL extension phase, topiramate will be titrated over 5 days to 200 mg/day. After Day 7, topiramate may be tapered down to 100 mg/day or up to 600 mg/day, as clinically indicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* DSM-IV diagnosis of Bipolar I Disorder (confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version \\[K-SADS-P/L\\])\n* YMRS score greater than or equal to 20\n* General good health as determined by medical history, physical examination, and laboratory evaluations\n* Ability to swallow tablets\n* Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment\n* Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from patients\n\nExclusion Criteria:\n\n* DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS)\n* DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within the 3 months prior to baseline. Acute or intermittent substance abuse prior to screening will not be exclusionary, depending upon the clinical judgment of the investigator\n* Chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis\n* Weight less than 33 kg or current or past history of anorexia nervosa\n* Serious or unstable medical or neurological conditions"}, 'identificationModule': {'nctId': 'NCT00035802', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A Randomized, Double-Blind, Multicenter, Placebo-Controlled 4-Week Study of the Safety and Efficacy of Topiramate in Adolescents With Acute Manic or Mixed Episodes of Bipolar I Disorder, With an Optional 6-Month Open-Label Extension', 'orgStudyIdInfo': {'id': 'CR016867'}, 'secondaryIdInfos': [{'id': 'TOPMAT-PDMD-009'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '001', 'description': 'Topiramate Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days.\n\nOL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.', 'interventionNames': ['Drug: Topiramate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '002', 'description': 'Placebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Topiramate', 'type': 'DRUG', 'description': 'Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days.\n\nOL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.', 'armGroupLabels': ['001']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.', 'armGroupLabels': ['002']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'SR DIRECTOR CLINICAL LEADER', 'oldOrganization': 'Johnson & Johnson Pharmaceutical Research and Development, L.L.C.'}}}}