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

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00034749
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief 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.

Detailed Description

This is a clinical study of an investigational drug called risperidone in the treatment of schizophrenia in adolescents. Initially children (age 2 to 12 yrs) and schizophreniform subjects were also allowed but excluded following protocol amendment.

The study will include approximately 260 patients aged 13 to 17 years with a diagnosis of schizophrenia. Subjects will be randomly assigned to one of two groups on enrollment and will be given risperidone as an oral solution each day for 8 weeks at doses within one of two dose different ranges, according to the assigned study group.

Initially the two dose range were 0.15-0.4 mg/day and 1.5-4mg/day but were changed in protocol amendment to evaluate the maximum tolerated dose with a minimum of 3.5mg/day and maximum of 6mg/day (resp. 0.35 and 0.6mg/day in low dose treatment arm) Risperidone lower dose (0.35-0.6 mg/day \[subjects \>=50kg\] or 0.007-0.012 mg/kg/day \[subjects \<50 kg\]) as 0.1 mg/mL oral solution or risperidone higher dose (3.5-6 mg/day \[subjects \>=50 kg\] or 0.07-0.12 mg/kg/day \[subjects \<50 kg\]) as 1 mg/mL oral solution for 8 weeks. Daily dose can be given all at once or through 2 administrations (in morning and evening); the dose is increased based on efficacy and tolerability.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Study Completion: 2006-03
• Status Verified: 2010-03
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint

Secondary Outcome Measures

Name	Time	Method
Change from baseline in PANSS subscale scores and Clinical Global Impression (CGI-S and CGI-I) scores, number of subjects achieving a clinical response (at least 20% improvement in total PANSS), safety, tolerability and pharmacokinetics.