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A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients
This study has been completed.
Sponsored by: Janssen Pharmaceutical K.K.
Information provided by: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00653406
  Purpose

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

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
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

Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 24
Study Start Date: November 2002
Study Completion Date: October 2003
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.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653406

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

A pharmacokinetic and safety study of risperidone long acting injectable in schizophrenic patients  This link exits the ClinicalTrials.gov site

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

Keywords provided by Janssen Pharmaceutical K.K.:
Pharmacokinetics
Intramuscular injection
Schizophrenia
Risperidone

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009