A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia

NCT ID: NCT00246285

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2006-12-31

Brief Summary

The purpose of the study is to assess the safety and effectiveness of risperidone (an antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment.

Detailed Description

Although the safety and effectiveness of antipsychotic medications is well-established in adults with schizophrenia, these drugs have not been examined rigorously in adolescents with this disorder. Preliminary experience suggests that risperidone may hold promise for the treatment of these younger subjects. This is an open-label, multicenter trial of risperidone, formulated as an oral solution and tablets, in the treatment of adolescents with schizophrenia. It is an open-label, 6-month extension of two previous double-blind studies that assessed the safety and effectiveness of risperidone in the treatment of schizophrenia in an adolescent population. Patients may also enroll directly in this open-label trial. During the first week of the study, patients will receive increasing doses of risperidone to reach an optimal daily dose (2 to 6 mg/day), which will be maintained throughout the 6 months of the study. Assessments of effectiveness include the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), a scale measuring the symptoms of schizophrenia, the Clinical Global Impression-Severity of Illness subscale (CGI-Severity), a scale measuring the severity of illness, the Clinical Global Impression-Improvement subscale (CGI-Improvement), a scale measuring clinical improvement, and the Children's Global Assessment Scale. Safety evaluations include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure, pulse, and temperature), weight, and electrocardiogram (ECG) recordings at specified intervals. The study hypothesis is that risperidone with be effective in the treatment of adolescents with schizophrenia, and well tolerated. Risperidone, oral solution (1 mg/ml) once daily; dose increasing from 0.01 mg/kg body weight (Day 1) to a range from 2 to 6 mg/day for 6 months. Oral tablets (0.5, 1, 2, 3, and 4 mg) once daily; dose increasing from 0.5 mg (Day 1) to a range of 2 to 6 mg/day for 6 months.

Conditions

Schizophrenia; Psychotic Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

risperidone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
• expected to benefit from continuous treatment with risperidone, including patients who cannot tolerate their current antipsychotic therapy or are still exhibiting symptoms
• Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score between 40 and 120 at start of study (not required for patients continuing from the 2 previous studies)

Exclusion Criteria

• Meet criteria for other psychiatric disorders or mental retardation (documented IQ <70)
• history of substance dependence (including alcohol, but excluding nicotine and caffeine)
• hypersensitivity or intolerance to risperidone
• extrapyramidal symptoms (EPS) such as tremor that are not adequately controlled with medication

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References

Pandina G, Kushner S, Karcher K, Haas M. An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia. Child Adolesc Psychiatry Ment Health. 2012 Jun 7;6(1):23. doi: 10.1186/1753-2000-6-23.

Reference Type: DERIVED

PMID: 22676070 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=522&filename=CR003364_CSR.pdf

A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia

Other Identifiers

CR003364

Identifier Type: -

Identifier Source: org_study_id