A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients

Study Overview
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Brief Summary
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The purpose of this study is to explore the pharmacokinetic profile and safety after biweekly (every 2-week) intramuscular (IM) injections (6 injections) of risperidone long acting injectable 25, 37.5, or 50 mg/dose in schizophrenic patients. The efficacy of the study medication will also be assessed.

Detailed Description
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This is an open-label, multicenter, randomized, 3-arm trial to compare the pharmacokinetic profile and the safety profile between 3 dose groups. There are 2 periods in this study: a 10-week treatment period and an 8-week follow-up period. Patients will receive 6 injections of long acting injectable risperidone at one of the dose levels (25, 37.5 and 50 mg) every 2 weeks according to their randomly assigned treatment. Blood samples will be collected throughout the 10-week treatment and 8-week follow-up period to determine the changes in study drug concentration in the plasma. Safety will be assessed by monitoring of adverse events, subjective symptoms/objective findings, laboratory tests, physical examinations, electrocardiograms, injection site reactions, and the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS). Efficacy of the study drug will be assessed based on the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression - Severity (CGI-S) and Clinical Global Impression - Change (CGI-C) scales. The patients will receive injections of long acting injectable risperidone (either 25, 37.5, or 50 mg) in their muscle every 2 weeks for 10 weeks for a total of 6 injections.

Official Title
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Multiple-dosing Study of Long Acting Injectable of Risperidone in Schizophrenic Patients

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Risperidone long acting injectable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese patients with a DSM-IV diagnosis of schizophrenia A Positive and Negative Syndrome Scale (PANSS) total score between 60 (included) and 120 (excluded) In- or out-patients (change of institutionalization status during the trial period is allowed). Exclusion Criteria: No DSM-IV diagnosis other than schizophrenia No convulsive disorders such as epilepsy No neuroleptic malignant syndrome or physical fatigue associated with dehydration, malnutrition No present illness or history of diabetes or risks of diabetes such as hyperglycemia and obesity No hemorrhagic diathesis.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperidone long acting injectable|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The max and min plasma concentrations, average plasma concentration, and time to reach the max plasma concentration at steady-state (2 weeks after 6th dose). Safety data for all timepoints will be summarized. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change at Week 12 from the baseline of the total score, positive symptom score, negative symptom score, total psychiatric score and BPRS scores from the PANSS. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Risperidone, Intramuscular injection, Pharmacokinetics