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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00034749

CR003361

Details and patient eligibility

About

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.

Full 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.

Enrollment

279 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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.