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

• Status: Completed
• Trial end date: 1999-04-01
• 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: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

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

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

• inpatient for a minimum of the first 4 days of double-blind treatment

• therapy with lithium or valproate (mood stabilizers) at start of treatment with study medication

• 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 4 weeks of starting the study

• seizure disorder requiring medication

• known sensitivity to risperidone, haloperidol, lithium, valproate or carbamazepine

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