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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00249223
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : January 14, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorders Drug: Risperidone Long acting injectable Phase 3

Detailed Description:
Chronic schizophrenia is a longer-term condition that is characterized by a lack of drive, underactivity and slowness, and social withdrawal. As with the acute form of schizophrenia, delusions and hallucinations are common. Based on the severity and long-term nature of this disease, it is important that patients take their antipsychotic medication regularly. Long-acting injectable forms of antipsychotic drugs may eliminate the need for daily oral medication and increase a patient's compliance in taking their medication as prescribed by their physician. This is a randomized, double-blind, parallel-group study comparing the effectiveness and safety of an injectable formulation of risperidone (coated microspheres) to risperidone tablets in patients with chronic, stable schizophrenia. The study is composed of a screening visit, followed by two study phases: an 8-week run-in period and a 12-week double-blind period. In the run-in phase, patients discontinue from other antipsychotic drugs, begin receiving oral risperidone, and stay on the optimal oral risperidone dose that is determined for each patient for 4 weeks before starting the double-blind period. Patients are then randomized to either risperidone tablets or the injectable risperidone formulation at the dose level established during the last 4 weeks of run-in. For the next 12 weeks patients receive an injection of risperidone every 2 weeks plus daily oral doses of placebo or receive a placebo injection every 2 weeks plus daily oral doses of resperidone tablets. The primary measure of effectiveness is the change from baseline in the total score for the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), a rating scale that measures the symptoms of schizophrenia. Additional efficacy testing includes the Clinical Global Impressions (CGI), a rating system used to evaluate the severity of clinical change in a patient with various diseases affecting the brain. Safety evaluations include the incidence of adverse events, results of clinical laboratory tests (hematology, biochemistry, urinalysis), measurements of vital signs and body weight, physical examination and electrocardiogram (ECG) findings, clinical examination of the injection area (buttocks), and the Extrapyramidal Symptoms Rating Scale (ESRS), a scale used to measure effects of antipsychotic medications on motor functions of the patient. The study hypothesis is that the injectable formulation of risperidone will not be less effective than oral risperidone tablets. The injectable formulation of risperidone will be considered less effective than oral risperidone if the improvement in total PANSS with injectable risperidone is more than 6 points worse than the improvement with oral risperidone. Risperidone injections (25, 50 or 75milligrams [mg]) starting Day 1 of the double-blind phase, then every 2 weeks (total of 12 weeks) or 2, 4, or 6mg/day risperidone tablets, starting Day 1 of the run-in period and continuing for the rest of the study.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 641 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Risperidone Depot (Microspheres) vs. Risperidone Tablets - a Non-inferiority, Efficacy Trial in Subjects With Schizophrenia
Study Start Date : January 2000
Study Completion Date : December 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline to end of double-blind treatment in the total score for PANSS.

Secondary Outcome Measures :
  1. CGI Severity Scale; safety evaluations conducted throughout the study.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
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): NCT00249223


Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00249223     History of Changes
Other Study ID Numbers: CR006061
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: January 14, 2011
Last Verified: January 2011

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
chronic schizophrenia, psychotic disorder, risperidone, long-acting injectable, intramuscular injection, antipsychotic agents

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Risperidone
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