A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Risperidone long acting injectable
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Intramuscular injection, Pharmacokinetics
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.
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00653406
First Posted
April 1, 2008
Last Updated
May 16, 2011
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT00653406
Brief Title
A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients
Official Title
Multiple-dosing Study of Long Acting Injectable of Risperidone in Schizophrenic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Risperidone, Intramuscular injection, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risperidone long acting injectable
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K. Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=402&filename=CR003262_CSR.pdf
Description
A pharmacokinetic and safety study of risperidone long acting injectable in schizophrenic patients
Learn more about this trial
A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients
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