A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness and safety over 1 year of treatment of intramuscular injections of paliperidone palmitate and long-acting risperidone 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; Risperidone

Criteria

Inclusion Criteria:

• A diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated types) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) for at least 1 year before the screening evaluation

• a total PANSS score of 60 to 120 at screening and baseline (pre-treatment) evaluations

• a body mass index (BMI [weight (kilograms)]/[height (meters)]²) of at least 15.0 kg/m² .

Exclusion Criteria:

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

• a decrease of 25% or more in the total PANSS score between screening and baseline evaluations

• a DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation

• a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications

• a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.