The Efficacy 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 Adolescents With Schizophrenia: a Comparison of Two Dose Ranges of Risperidone

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

279

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:

  • 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint

Secondary Outcome Measures

Outcome Measure
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.

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)

March 1, 2006

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

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

  • CR003361

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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