The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Subjects will be eligible for study enrollment if they: are adolescents between the ages of 13 and 17 years

• have a confirmed diagnosis of schizophrenia and are suffering from an acute episode

• provide their assent and parental informed consent to participate

• are otherwise relatively healthy on the basis of a medical and physical examination

• and are able to be in-patients for approximately 2 weeks.

Exclusion Criteria:

• Subjects will be excluded from the study if they: meet the criteria for psychiatric disorders other than schizophrenia

• have moderate or severe mental retardation

• fail to respond to treatment with at least two typical or atypical antipsychotics

• have a history of substance dependence within the 3 months before screening

• are considered at risk for suicidal or violent behavior

• have a seizure disorder

• have a history of neuroleptic malignant syndrome, similar encephalopathic syndrome, or tardive dyskinesia

• or receive prohibited medication within a specified period before screening.