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

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The Efficacy And Safety Of Risperidone In The Treatment Of Adolescents With Schizophrenia: A Six-Month Open-Label Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change of Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score from baseline to each visit during treatment; incidence of adverse events throughout study

Secondary Outcome Measures

Outcome Measure
Clinical Global Impression-Severity of Illness (CGI-Severity) and Clinical Global Impression-Improvement (CGI-Improvement) at each visit; Children's Global Assessment Scale at start and end of study; clinical laboratory tests, vital signs, weight, ECGs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (Estimate)

October 30, 2005

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003364

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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