- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00249132
A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol and Placebo in Patients With Chronic Schizophrenia
Risperidone Versus Haloperidol Versus Placebo in the Treatment of Chronic Schizophrenia
Study Overview
Status
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. This is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of four dosages of risperidone (2, 6, 10 or 16 mg/day) compared with placebo and with a fixed 20 mg/day dose of a standard antipsychotic, haloperidol in patients with chronic schizophrenia who are in-patients at the beginning of the study.
The study is composed of two phases: a 1-week period, in which patients receive placebo and all current medication for schizophrenia treatment is stopped, followed by a double-blind treatment phase. The doses of study drug are increased progressively during the first week of the double-blind period and then remain constant for the next 7 weeks. The primary measures of effectiveness are the percentage of patients showing clinical improvement (reduction of >=20% from baseline) on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the total PANSS score, from baseline to end of double-blind treatment. The PANSS is a rating scale that measures the symptoms of schizophrenia. Safety evaluations include the incidence of adverse events, results of clinical laboratory tests (hematology, biochemistry, and urinalysis), plasma levels of risperidone, measurements of vital signs and body weight, physical examination and electrocardiogram (ECG) findings, neurological examinations, 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 risperidone is more effective than placebo, as measured by clinical improvement on PANSS and the average total score for PANSS, in patients with chronic schizophrenia. Risperidone tablets, taken orally, starting with 1 mg twice daily, gradually increasing dose in Week 1 (except for 1 mg twice daily group), then 1, 3, 5, or 8 mg twice daily, continuing for 7 weeks. Haloperidol tablets, starting 1 mg twice daily and increasing to 10 mg twice daily (Week 1), continuing 10 mg twice daily for 7 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with diagnosis of chronic schizophrenic disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 3rd edition (DSM-III-R) criteria and are inpatients at the beginning of study
- total score on the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) rating scale at study entry of >=60 and <=120
- females of childbearing age must demonstrate adequate birth control measures and have a negative pregnancy test before study entry.
Exclusion Criteria:
- Patients with mental disorders other than chronic schizophrenic disorder
- patients with clinically significant organic or neurological diseases
- patients with epilepsy
- history of alcohol or drug abuse history within the 6 months before study entry.
Study Plan
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 |
---|
Percent of patients showing clinical improvement, defined as a >=20% reduction in the total PANSS score from baseline to end of double-blind treatment, and the mean change from baseline to end of double-blind treatment in total PANSS score.
|
Secondary Outcome Measures
Outcome Measure |
---|
Mean PANSS Positive Subscale Score; Mean PANSS Negative Subscale Score; mean PANSS General Psychopathology Subscale Score; CGI severity; CGI overall change from baseline; safety evaluations conducted throughout the study.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Marder SR, Meibach RC. Risperidone in the treatment of schizophrenia. Am J Psychiatry. 1994 Jun;151(6):825-35. doi: 10.1176/ajp.151.6.825.
- Chouinard G, Jones B, Remington G, Bloom D, Addington D, MacEwan GW, Labelle A, Beauclair L, Arnott W. A Canadian multicenter placebo-controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic patients. J Clin Psychopharmacol. 1993 Feb;13(1):25-40. Erratum In: J Clin Psychopharmacol 1993 Apr;13(2):149.
- Marder SR, Davis JM, Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J Clin Psychiatry. 1997 Dec;58(12):538-46. doi: 10.4088/jcp.v58n1205. Erratum In: J Clin Psychiatry 1998 Apr;59(4):200.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- CR006067
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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