A Comparison of the Pharmacokinetics and Safety of Long-acting Injectable Risperidone When Administered to Gluteal or Deltoid Intramuscular Injection Sites in Stable Schizophrenia Patients.

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the pharmacokinetics and safety of long-acting injectable risperidone, an atypical antipsychotic medication used for the treatment of patients with schizophrenia, when it is administered as an intramuscular injection via the deltoid muscle, compared with intramuscular injection via the gluteal muscle.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Chronic schizophrenia of any subtype, according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria

• stable schizophrenia without any changes in medications or dosage during the 4 weeks before the screening visit

• Clinical Global Impression scale score of <=3 (mild)

• informed consent signed by the patient

• patient is otherwise healthy on the basis of a prestudy physical examination and medical history.

Exclusion Criteria:

• No DSM-IV Axis I diagnosis other than schizophrenia

• no pregnant or breast feeding women

• no female subject of childbearing potential without adequate contraception

• no history of severe drug allergy or hypersensitivity

• no patients with inadequate mass in the gluteal or deltoid regions to receive the intramuscular drug injections.