The Efficacy and Safety of Risperidone in Adolescents With Schizophrenia: a Comparison of Two Dose Ranges of Risperidone
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Enrollment
- 279
- Primary Endpoint
- Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
Secondary Outcomes
- 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.