A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol in 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. Identifier: NCT00249119
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : February 11, 2011
Information provided by:
Janssen, LP

Brief Summary:
The purpose of the study is to evaluate the effectiveness and safety of different doses of risperidone (an antipsychotic medication) compared with a fixed 10-mg dose of a standard antipsychotic, haloperidol, in patients with chronic schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorder Drug: risperidone 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. This is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of five dosages of risperidone (1, 4, 8, 12, or 16 mg per day) compared with a fixed dose of a standard antipsychotic, haloperidol (10 mg per day) in patients with chronic schizophrenia. 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, and 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 percent of patients showing clinical improvement on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the average total PANSS score, from baseline to the 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, urinalysis, and hormone levels), 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 doses of 4, 8, 12, or 16 mg/day are more effective than risperidone 10 mg/day, as measured by clinical improvement on PANSS and the average total score for PANSS, in patients with chronic schizophrenia. Risperidone oral tablets, twice-daily, starting with 1 or 2 mg/day, increasing gradually in Week 1 (except for 1 mg/day group), then 0.5, 2, 4, 6, or 8 mg twice daily for 7 weeks. Haloperidol oral tablets, twice-daily, starting with 2 mg/day, increasing to 5 mg twice daily in Week 1, then 5 mg twice daily for 7 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Risperidone in the Treatment of Chronic Schizophrenic Patients: an International Multicentre Double-blind Parallel-group Comparative Study Versus Haloperidol.
Actual Study Completion Date : December 1991

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. Mean PANSS Positive Subscale Score; Mean PANSS Negative Subscale Score; mean PANSS General Psychopathology Subscale Score; mean separate PANSS item scores; safety evaluations conducted throughout the study.

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

Inclusion Criteria:

  • Diagnosis of chronic schizophrenic disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 3rd edition (DSM-III-R) criteria
  • total score on the PANSS at study entry of >=60 and <=120
  • physical and neurological examination and ECG findings and clinical hematology, biochemistry, and urinalysis test results within normal limits before study entry
  • patients must be able to be hospitalized the first 3 weeks of the study, if possible.

Exclusion Criteria:

  • Patients with mental disorders other than chronic schizophrenic disorder
  • patients with clinically significant organic or neurologic diseases
  • women who are pregnant or breastfeeding, and women of childbearing potential without adequate birth control measures
  • patients with epilepsy
  • history of alcohol or drug abuse history within the previous 12 months.

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 identifier (NCT number): NCT00249119

Sponsors and Collaborators
Janssen, LP
Study Director: Janssen, LP Clinical Trial Janssen, LP

Publications of Results: Identifier: NCT00249119     History of Changes
Other Study ID Numbers: CR006043
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011

Keywords provided by Janssen, LP:
chronic schizophrenia
psychotic disorders
antipsychotic agents

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Haloperidol decanoate
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
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Dyskinesia Agents