A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00035802

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders	Drug: Topiramate Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Child Mental Health Mental Disorders Psychotic Disorders

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Change from baseline in total Young Mania Rating Scale (YMRS) score [ Time Frame: Baseline to Day 28 (or last available observation prior to Day 28). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Clinical Global Impression Scale (CGI-S) score [ Time Frame: Baseline to Day 28 (or last available observation prior to Day 28). ] [ Designated as safety issue: No ]
Change from baseline in Children's Global Assessment Scale (C-GAS) score [ Time Frame: Baseline to Day 28 (or last available observation prior to Day 28). ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 28 (or last available observation prior to Day 28) ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	January 2002
Study Completion Date:	April 2002

Arms	Assigned Interventions
Experimental: 001 Topiramate Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.	Drug: Topiramate Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.
Placebo Comparator: 002 Placebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.	Drug: Placebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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])
YMRS score greater than or equal to 20
General good health as determined by medical history, physical examination, and laboratory evaluations
Ability to swallow tablets
Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment
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

Exclusion Criteria:

DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS)
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
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
Weight less than 33 kg or current or past history of anorexia nervosa
Serious or unstable medical or neurological conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035802

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

No publications provided

Responsible Party:	SR DIRECTOR CLINICAL LEADER, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00035802 History of Changes
Other Study ID Numbers:	CR016867, TOPMAT-PDMD-009
Study First Received:	May 6, 2002
Last Updated:	June 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Bipolar
Mania
Pediatric
Children
Adolescent

Topiramate
Anticonvulsants
Central Nervous System Agents
Protective Agents
Neuroprotectiive Agents

Additional relevant MeSH terms:

Affective Disorders, Psychotic
Mental Disorders
Psychotic Disorders
Bipolar Disorder
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Agents
Topiramate

Therapeutic Uses
Pharmacologic Actions
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on February 12, 2012