A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the safety and effectiveness of risperidone (an antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment.

• 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 schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)

• expected to benefit from continuous treatment with risperidone, including patients who cannot tolerate their current antipsychotic therapy or are still exhibiting symptoms

• Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score between 40 and 120 at start of study (not required for patients continuing from the 2 previous studies)

Exclusion Criteria:

• Meet criteria for other psychiatric disorders or mental retardation (documented IQ <70)

• history of substance dependence (including alcohol, but excluding nicotine and caffeine)

• hypersensitivity or intolerance to risperidone

• extrapyramidal symptoms (EPS) such as tremor that are not adequately controlled with medication