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

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ClinicalTrials.gov Identifier: NCT00653406
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Janssen Pharmaceutical K.K.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Risperidone long acting injectable Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiple-dosing Study of Long Acting Injectable of Risperidone in Schizophrenic Patients
Study Start Date : November 2002
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653406


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

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ClinicalTrials.gov Identifier: NCT00653406    
Other Study ID Numbers: CR003262
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: March 2010
Keywords provided by Janssen Pharmaceutical K.K.:
Schizophrenia
Risperidone
Intramuscular injection
Pharmacokinetics
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents