A Comparison of the Effectiveness and Safety of Injectable Risperidone With That of Risperidone Tablets in the Treatment of Patients With Chronic Schizophrenia

NCT00249223 | Completed Phase 3

• 1 other identifier: CR006061
• Study Type: interventional
• Target: 641
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of the study is to show that treatment with an injectable formulation of risperidone is not less effective than and has a similar safety profile to risperidone tablets in patients with chronic schizophrenia.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

chronic schizophrenia, psychotic disorder, risperidone, long-acting injectable, intramuscular injection, antipsychotic agents

Outcome Measures

Primary Outcomes (1)

• Change from baseline to end of double-blind treatment in the total score for PANSS.

Secondary Outcomes (1)

• CGI Severity Scale; safety evaluations conducted throughout the study.

Interventions

Risperidone Long acting injectable DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria
• total score on the PANSS at study entry of \>=50
• before trial entry, results of clinical hematology, biochemistry, and urinalysis tests performed at screening visit are within normal ranges
• women of child-bearing age must use adequate birth control methods, have a negative pregnancy test before the start of risperidone treatment, and not be breast feeding
• patients' schizophrenia symptoms are stable for the last 4 weeks of the run-in period.

You may not qualify if:

• Patients with a DSM-IV Axis I diagnosis other than schizophrenia
• documented disease of the central nervous system that can interfere with the trial assessments, for example stroke, tumor, Parkinson's Disease, Alzheimer's Disease
• moderate or severe symptoms at screening of tardive dyskinesia, a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs
• history of neuroleptic malignant syndrome, a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state
• acute, unstable or other significant and untreated medical conditions, such as infections, unstable diabetes, or unstable hypertension.

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Related Publications (1)

• Chue P, Eerdekens M, Augustyns I, Lachaux B, Molcan P, Eriksson L, Pretorius H, David AS. Comparative efficacy and safety of long-acting risperidone and risperidone oral tablets. Eur Neuropsychopharmacol. 2005 Jan;15(1):111-7. doi: 10.1016/j.euroneuro.2004.07.003.

  PMID: 15572280 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 7, 2005
• Study Start: January 1, 2000
• Study Completion: December 1, 2000
• Last Updated: January 14, 2011

Record last verified: 2011-01