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

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00653406
First received: April 1, 2008
Last updated: May 16, 2011
Last verified: March 2010
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multiple-dosing Study of Long Acting Injectable of Risperidone in Schizophrenic Patients

Resource links provided by NLM:


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.

Enrollment: 29
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00653406     History of Changes
Other Study ID Numbers: CR003262
Study First Received: April 1, 2008
Last Updated: May 16, 2011
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 22, 2014