An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia

Summary

The purpose of this study is to evaluate the efficacy and safety of paliperidone palmitate as compared with placebo in the treatment of participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions \[a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder\] and hallucinations \[imagining things\], and withdrawal into the self).

Timeline

Start

2010-10

Primary completion

2012-05

Completion

2012-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo (Double-blind) vs Paliperidone Palmitate (Double-blind); p <0.0001; Least squares (LS) means difference -9.7 (95% CI -14.0 to -5.4); ANCOVA NCT01299389 ↗

Drugs

Indications