INVEGA TRINZA® Provides Significant Symptom Improvement in PANSS Total Scores1
PANSS total score over time1
PANSS=Positive and Negative Syndrome Scale.
The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5®, or current version), where applicable.
Study design of long-term maintenance trial1,2:
A randomized, double-blind, placebo-controlled, long-term maintenance study compared 3-month paliperidone palmitate (INVEGA TRINZA®) to placebo in adult patients with schizophrenia. Patients were treated for 17 weeks with 1-month paliperidone palmitate (INVEGA SUSTENNA®) during an open-label, flexible-dose stabilization phase, and then a single dose of INVEGA TRINZA® during an open-label maintenance phase. This was followed by a fixed dose of INVEGA TRINZA® or placebo once every 3 months in a variable-duration, double-blind phase. A preplanned interim analysis conducted by an Independent Data Monitoring Committee after 42 relapse events resulted in the decision to terminate the study early due to significant efficacy favoring INVEGA TRINZA®.
References: 1. Berwaerts J, Liu Y, Gopal S, et al. Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2015;72(8):830-839. Supplemental data available at: http://archpsyc.jamanetwork.com/article.aspx?articleid=2211343#tab12. Accessed June 15, 2017. 2. INVEGA TRINZA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; February 2017.