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Sponsored by: |
Janssen Pharmaceutical K.K. |
---|---|
Information provided by: | Janssen Pharmaceutical K.K. |
ClinicalTrials.gov Identifier: | NCT00653406 |
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.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Risperidone long acting injectable |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Multiple-Dosing Study of Long Acting Injectable of Risperidone in Schizophrenic Patients |
Estimated Enrollment: | 24 |
Study Start Date: | November 2002 |
Study Completion Date: | October 2003 |
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.
Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003262 |
Study First Received: | April 1, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00653406 |
Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
Pharmacokinetics Intramuscular injection Schizophrenia Risperidone |
Schizophrenia Dopamine Mental Disorders Risperidone |
Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |