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

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Risperidone

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.