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

NCT ID: NCT00653406

Last Updated: 2011-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2003-10-31

Brief Summary

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

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Risperidone long acting injectable

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Janssen Pharmaceutical K.K. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=402&filename=CR003262_CSR.pdf

A pharmacokinetic and safety study of risperidone long acting injectable in schizophrenic patients

Other Identifiers

CR003262

Identifier Type: -

Identifier Source: org_study_id