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

NCT ID: NCT00035802

Last Updated: 2011-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2002-04-30

Brief Summary

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.

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.

Conditions

Bipolar Disorder; Affective Disorders, Psychotic; Mood Disorders; Mental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Topiramate

Intervention Type: DRUG

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.

002

Placebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.

Interventions

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.

Intervention Type: DRUG

Placebo

Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

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

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Other Identifiers

TOPMAT-PDMD-009

Identifier Type: -

Identifier Source: secondary_id

CR016867

Identifier Type: -

Identifier Source: org_study_id