Overview

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

Status:
Completed
Trial end date:
2002-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatments:
Topiramate
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