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A Study of the Efficacy and Safety of Long-acting Injectable Risperidone and Risperidone Tablets in Patients With 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: NCT00240708
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : May 17, 2011
Information provided by:
Janssen Pharmaceutical K.K.

Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of risperidone, formulated as a long-acting injectable drug, compared with risperidone tablets in the treatment of patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: risperidone Phase 3

Detailed Description:
Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This is an open-label, randomized, Phase III trial in patients with schizophrenia. One treatment group receives 25 to 50 mgs of long-acting risperidone, formulated for intramuscular injections, at study initiation and again after 2 weeks, while phasing out any previous antipsychotic medication during the initial 3 weeks of the study. Continuing in the treatment phase, long-acting injections are administered once every 2 weeks through Week 24, and post-treatment observation is performed for 6 weeks (total study duration of 30 weeks). Patients in the other treatment group take oral risperidone tablets, 2 to 6 mgs daily, from study initiation for 24 weeks. Post-treatment observation continues for 1 week for this group (total study duration of 25 weeks). Assessments of effectiveness made at specified intervals during treatment include Positive And Negative Syndrome Scale (PANSS), a scale for the measurement of symptoms of schizophrenia; Clinical Global Impression - Severity (CGI-S), a measure of overall severity of illness, and Clinical Global Impression - Changes (CGI-C); as well as, Brief Psychiatric Rating Scale (BPRS). Safety evaluations include the incidence of adverse events throughout the study; inspection of the injection site at times of treatment; Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS), vital signs (pulse, blood pressure, temperature), and laboratory tests (hematology, biochemistry, urinalysis) at monthly intervals. The study hypothesis is that treatment with long-acting risperidone injections is not inferior to oral risperidone, as measured by changes in PANSS total score from baseline through endpoint (24 weeks), in patients with schizophrenia and is generally well-tolerated. Risperidone, long-acting formulation for intramuscular injections (25 milligrams[mg] to 50mg, maximum), given biweekly through 24 weeks. Oral risperidone (2mg/day to 6mg/day [maximum]) administered daily for 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Parallel-Group Comparative Open-Label Study of Long-Acting Injectible Risperidone Versus Risperidone Tablets in Patients With Schizophrenia.
Study Start Date : June 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) at screening, Weeks 8, 16, and 24.

Secondary Outcome Measures :
  1. Clinical Global Impression-Changes (CGI-C), from baseline at Weeks 8, 16 and 24; Brief Psychiatric Rating Scale (BPRS) at baseline and biweekly from Weeks 4 through 18; Clinical Global Impressions-severity (CGI-S)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of schizophrenia by the criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th Edition (DSM-IV )
  • treatment with an antipsychotic drug (up to 6 milligrams/day of risperidone or equivalent dose) for 28 days before study initiation with no change in the dosage
  • Total Positive and Negative Syndrome Scale (PANSS) score >=60 and <120 at start of study.

Exclusion Criteria:

  • Diagnosis of mental disease other than schizophrenia
  • treated with a sustained-release injection of other antipsychotic medications within 60 days before the initiation of the study
  • history of cerebrovascular accident, convulsive disorder such as epilepsy, diabetes mellitus, liver disease, kidney disease, cardiovascular disorder, malignancy or physical exhaustion due to dehydration or malnutrition
  • have risk factors of diabetes mellitus, such as hyperglycemia.

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): NCT00240708

Sponsors and Collaborators
Janssen Pharmaceutical K.K.
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Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00240708    
Other Study ID Numbers: CR004945
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: March 2010
Keywords provided by Janssen Pharmaceutical K.K.:
intramuscular injection
antipsychotic agents
long-acting injectable
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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