- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00249223
A Comparison of the Effectiveness and Safety of Injectable Risperidone With That of Risperidone Tablets in the Treatment of Patients With Chronic Schizophrenia
January 13, 2011 updated by: Janssen Pharmaceutica N.V., Belgium
Risperidone Depot (Microspheres) vs. Risperidone Tablets - a Non-inferiority, Efficacy Trial in Subjects With Schizophrenia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
641
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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 from baseline to end of double-blind treatment in the total score for PANSS.
|
Secondary Outcome Measures
Outcome Measure |
---|
CGI Severity Scale; safety evaluations conducted throughout the study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
January 1, 2000
Study Completion (Actual)
December 1, 2000
Study Registration Dates
First Submitted
November 4, 2005
First Submitted That Met QC Criteria
November 4, 2005
First Posted (Estimate)
November 7, 2005
Study Record Updates
Last Update Posted (Estimate)
January 14, 2011
Last Update Submitted That Met QC Criteria
January 13, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Psychotic Disorders
- Mental Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- CR006061
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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