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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2006-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Risperidone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No