A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.

• Status: Completed
• Trial end date: 1999-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo as add-on therapy to mood stabilizers, in the treatment of manic episodes associated with bipolar disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Patients hospitalized for mania with a score >=20 on the Young Mania Rating Scale (YMRS). (Patients with symptoms of depression are eligible)

• diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)

• receiving treatment with a mood stabilizer for a minimum of 2 weeks prior to study initiation, or beginning therapy with a mood stabilizer prior to treatment with study medication

• patients medically stable on the basis of physical examination, medical history and electrocardiogram results.

Exclusion Criteria:

• Other Axis I DSM-IV diagnosis (except nicotine or caffeine dependence)

• history of alcohol or drug abuse or dependence within 3 months of starting the study

• seizure disorder requiring medication

• known sensitivity to risperidone, lithium, valproate or carbamazepine

• pregnant or nursing females, or those lacking adequate contraception.