- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00236457
A Study Comparing the Efficacy of Long-acting Injectable Risperidone and Olanzapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Randomized, Multi-center, Open Label Trial Comparing Risperidone Depot (Microspheres) and Olanzapine Tablets in Patients With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to document both short-term, as well as long-term efficacy and safety of a long-acting injectable formulation of risperidone, in comparison with olanzapine for the treatment of patients with schizophrenia or schizoaffective disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Many schizophrenia patients currently take oral antipsychotic medications daily, but long-acting injectable formulations may eliminate this need for the daily medication.
This is an open-label study of a flexible does of a long-acting formulation of risperidone injected into the muscle at 2 week intervals over 12 months in patients with schizophrenia or schizoaffective disorder.
A comparator group will receive daily tablets of olanzapine, a psychotropic agent available for the treatment of schizophrenia and schizoaffective disorders.
This is a two-part trial.
Patients will be titrated to the most effective dose of trial medication during the first 13 weeks and analyzed for short-term efficacy and safety of treatment at Week 13.
Patients will be then assessed for maintenance of efficacy, safety, and resource use at Week 52 (second part of study).
Efficacy assessments include the Structured Clinical Interview - Positive and Negative Syndrome Scale (SCI-PANSS), overall severity of illness measured by the Clinical Global Impression (CGI) scale, and quality of life assessed by Wisconsin Quality of Life Index (W-QOLI).
Safety evaluations include incidence of adverse events, Simpson and Angus Rating Scale for extrapyramidal symptoms, physical examinations, clinical laboratory tests (biochemistry, haematology, and urinalysis), and electrocardiograms (ECGs).
The primary study hypothesis is that treatment with long-acting risperidone injected intramuscularly every 2 weeks is not inferior to treatment with daily olanzapine in terms of short-term efficacy and is well tolerated by patients with schizophrenia or schizoaffective disorder.
Risperidone injections (25mg or 50mg) every 2 weeks for 12 months.
Investigator may decrease or increase dosages (max 50mg) or supplement risperidone injections with risperidone tablets (4mg/day max.).
Control group receives olanzapine tablets (5mg) daily, adjusted as necessary (max 20mg).
Study Type
Interventional
Enrollment (Actual)
629
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
- Positive and Negative Syndrome Scale (PANSS) total score =>50, indicating at least a minimum level of mental and behavioral disorders
- Recent hospitalization or an episode of psychosis requiring medical intervention
- Body Mass Index (BMI) <=40 (BMI >=30 indicates obesity)
Exclusion Criteria:
- Diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder
- History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
- Past treatment with clozapine
- Pregnant or nursing females, or those lacking adequate contraception
- Known sensitivity or unresponsiveness to risperidone or olanzapine
- Treatment with a long-acting injectable antipsychotic drug near the time of the trial start
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: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Mean change from baseline to Week 13 for total score using the Structured Clinical Interview- Positive and Negative Syndrome Scale (SCI-PANSS)
|
Secondary Outcome Measures
Outcome Measure |
---|
Change from baseline through each visit and at study end (Week 53) for SCI-PANSS total score, SCI-PANSS subscales, Clinical Global Impression (CGI) and Wisconsin Quality of Life Index (W-QOLI). Safety evaluations 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
November 1, 2000
Study Completion (Actual)
December 1, 2002
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Psychotic 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
- CR002026
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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