A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to document the pharmacokinetics of paliperidone following fixed multiple intramuscular injections of paliperidone palmitate 150 mg eq.

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

Details

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

Criteria

Inclusion Criteria:

• Meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening

• Have a body mass index (BMI) of >=17.0 kg/m2 at screening

• Have a Positive and Negative Syndrome Scale (PANSS) total score of <=70

Exclusion Criteria:

• Have a primary active DSM-IV Axis I diagnosis other than schizophrenia

• Have a PANSS total score of >70 at screening

• Have a PANSS score of >16 points on the sum of the following 4 items at screening and baseline: conceptual disorganization, suspiciousness/persecution, hallucinatory behavior, and unusual thought content

• Have scores greater than 5 on any of the individual items of the PANSS at screening or baseline

• Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator