Schizophrenia
Conditions
Keywords
Schizophrenia, Risperidone, Intramuscular injection, Pharmacokinetics
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.
Interventions
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed