A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in the Treatment of Patients With Schizophrenia

NCT00253136 | Completed Phase 3

• 1 other identifier: CR006055
• Study Type: interventional
• Target: 458
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare the effectiveness and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) versus placebo for the treatment of the symptoms of schizophrenia over a 12-week period.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

schizophrenia; schizoaffective disorder; psychotic disorder; risperidone; long-acting injectable; intramuscular injection; antipsychotic agents

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the end of double-blind treatment in the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) total score

Secondary Outcomes (1)

• PANSS subscale scores; CGI (Clinical Global Impressions) scores and change from baseline in CGI; SF-36 (Quality of Life) evaluations; safety evaluations conducted throughout the study

Interventions

risperidone DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria
• total score at study entry on the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) of \>=60 and \<=120
• patient is otherwise healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram (ECG) findings and results of clinical hematology, biochemistry, and urinalysis tests performed within 1 week of the start of risperidone treatment
• women of child-bearing age must be using an adequate method of birth control and have a negative pregnancy test before the start of risperidone treatment.

You may not qualify if:

• Patients receiving an injectable form of another antipsychotic (last injection within 120 days of screening)
• patients with a DSM-IV Axis I diagnosis other than schizophrenia
• DSM-IV diagnosis of substance dependence within 3 months of start of screening (nicotine and caffeine dependence are allowed)
• history or current symptoms of tardive dyskinesia (a condition seen in patients receiving long-term medication with certain types of antipsychotics in which the patients develop movements of the tongue, lips, face, trunk and hands and feet that they cannot control)
• history of neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which a patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state).

Sponsors & Collaborators

• Janssen, LP: lead

Related Publications (1)

• Kane JM, Eerdekens M, Lindenmayer JP, Keith SJ, Lesem M, Karcher K. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. Am J Psychiatry. 2003 Jun;160(6):1125-32. doi: 10.1176/appi.ajp.160.6.1125.

  PMID: 12777271 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen, LP Clinical Trial

  Janssen, LP

  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 10, 2005
• First Posted: November 15, 2005
• Study Start: November 1, 1999
• Study Completion: December 1, 2000
• Last Updated: December 3, 2010

Record last verified: 2010-12