Official Title: “A Parallel-Group Comparative Open-Label Study of Long-Acting Injectible Risperidone Versus Risperidone Tablets in Patients With Schizophrenia.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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, termperature), 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.

Intervention(s) in this Clinical Trial

• Drug: risperidone

Primary Measures

• Positive and Negative Syndrome Scale (PANSS) at screening, Weeks 8, 16, and 24.

Secondary Measures

• 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)

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen Pharmaceutical K.K.

Overall Clinical Trial Officials and Contacts

Janssen Pharmaceutical K.K. Clinical Trial Study Director Janssen Pharmaceutical K.K.  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00240708

Study ID Number: CR004945

ClinicalTrials.gov Identifier: NCT00240708

Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

A study of the Efficacy and Safety of Long-Acting injectible Risperidone and Risperidone tablets in patients with Schizophrenia.