Injection Site Tolerability of Multiple Dose Treatment With Long-acting Injectable Risperidone Administered Via Deltoid Muscle in Chronic Schizophrenia Patients.

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the discontinuation rate of schizophrenia patients receiving multiple sequential 2 mL injections of long acting injectable risperidone (an atypical antipsychotic medication) when administered into the deltoid muscle once every 2 weeks.

• 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 DSM-IV criteria

• under current treatment with long-acting injectable risperidone 25 mg or 37.5 mg gluteal injections in an adequate study for at least 2 injections, and in need of a dose increase of long-acting injectable risperidone for clinical reason

• 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 deltoid regions to receive the intramuscular drug injections.