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

Condition(s) targeted: Bipolar Disorder; Affective Disorders, Psychotic; Mood Disorders; Mental Disorders

Intervention: Topiramate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

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

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

Primary outcome: Change from baseline in total Young Mania Rating Scale (YMRS) score

Secondary outcome:

Change from baseline in Clinical Global Impression Scale (CGI-S) score

Change from baseline in Children's Global Assessment Scale (C-GAS) score

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

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.

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

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

Starting date: January 2002
Last updated: June 23, 2011