A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of intramuscular injections (to the buttocks or to the shoulders) of paliperidone palmitate in patients with schizophrenia.

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

Details

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

Criteria

Inclusion Criteria:

• The patient must have signed an informed consent

• The patient must meet the diagnostic criteria for schizophrenia

• Female patient must be postmenopausal for at least 2 years or have negative pregnancy test result at screening

• The patient must be able to perform study requirements (e.g. answer questionnaire)

Exclusion Criteria:

• Primary, active diagnosis other than schizophrenia

• Psychiatric inpatient hospitalization for relapse of symptoms of schizophrenia in the past 90 days

• Change in their antipsychotic medication in the past 45 days

• Diagnosis of active substance dependence within 3 months

• History of treatment resistance

• History of concurrent significant or unstable diseases (e.g. heart, lung, or liver diseases)