Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief 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.
Detailed Description
Although the safety and effectiveness of antipsychotic medications is well-established in adults with schizophrenia, these drugs have not been examined rigorously in adolescents with this disorder. Pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT00246285
Start Date
April 1 2001
End Date
December 1 2006
Last Update
June 8 2011
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