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Investigate Risperidone for the Treatment of Schizophrenia in Adolescents

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ClinicalTrials.gov Identifier: NCT00088075
Recruitment Status : Completed
First Posted : July 21, 2004
Last Update Posted : June 8, 2011
Information provided by:

Study Description
Brief Summary:
A clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a sugar pill) in adolescents (aged 13 to 17 years) with schizophrenia (i.e. abnormal behavior and thoughts). The study duration is about 6 to 7 weeks.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Risperidone Phase 3

Detailed Description:
Subjects will be aged 13 to 17 years with a diagnosis of schizophrenia. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 1 to 3 mg, or oral risperidone tablets 4 to 6 mg), which will be administered daily for 6 weeks. Study medication will be increased to within the target dosage range during the first 7 days and then further increased until the maximum tolerated dose is achieved by day 14. The maximum tolerated dose will be maintained for the last 4 weeks of the study, unless dose adjustments are agreed with the Sponsor. Risperidone (1 to 3 mg or 4 to 6 mg) or placebo given orally as 0.5, 1, 2, 3, or 4 ,g tablets (or matching placebo) each day for 6 weeks.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Risperidone for the Treatment of Schizophrenia in Adolescents
Study Start Date : August 2004
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 6-week endpoint

Secondary Outcome Measures :
  1. 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 and tolerability.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A responsible person must be available to accompany the subject to the site at each visit
  • patient must meet the DSM-IV criteria for schizophrenia

Exclusion Criteria:

  • Patients with mild, moderate or severe mental retardation
  • patients with a known or suspected history of substance dependence
  • subjects weighing <35kg
  • subjects who cannot swallow oral tablets
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088075

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00088075     History of Changes
Other Study ID Numbers: CR003370
First Posted: July 21, 2004    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: January 2011

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents