Efficacy and safety of paliperidone extended-release in schizophrenia patients with prominent affective symptoms.

Author(s): Canuso CM, Turkoz I, Sheehan JJ, Bossie CA

Affiliation(s): Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ 08560-0200, USA. CCanuso@its.jnj.com

Publication date & source: 2010-01, J Affect Disord., 120(1-3):193-9.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: This post-hoc analysis evaluated the effects of paliperidone extended-release (ER) in patients with schizophrenia and prominent affective symptoms. METHODS: Pooled data from three 6-week, randomized, double-blind, placebo-controlled studies were analyzed. Subjects received fixed doses of paliperidone ER 3-12 mg/day or placebo. Prominent affective symptoms were defined as depressive (Positive and Negative Syndrome Scale [PANSS] depression item score of > or =5 [moderately severe]) and/or manic (PANSS grandiosity score of > or =4 [moderate], plus a score of > or =4 [moderate] on at least 1 PANSS item for excitement, hostility, uncooperativeness, or poor impulse control). Assessments included PANSS, Clinical Global Impressions-Severity (CGI-S), Personal and Social Performance (PSP) scale, and adverse events (AEs). RESULTS: Among 193 patients with prominent affective symptoms, 140 received paliperidone ER and 53 received placebo. Paliperidone ER showed significant mean (SD) improvements vs. placebo in PANSS total (-20.5 [23.8] vs. -6.3 [27.2]; p<0.001, respectively) and all factor scores (p<0.01). Significant mean (SD) improvements were observed in PSP (7.2 [15.8] vs. 0.4 [14.6]; p=0.004) and CGI-S (-0.9 [1.2] vs. -0.3 [1.2]; p<0.001) scores. Most common AEs with paliperidone ER vs. placebo: headache (16.4% vs. 13.2%), insomnia (7.9% vs. 9.4%), akathisia (7.1% vs. 1.9%), sedation (7.1% vs. 3.8%). LIMITATIONS: These studies were not designed to examine patients with prominent affective symptoms. Authors' clinical judgment was used to define prominent affective symptoms, using relevant PANSS items. CONCLUSIONS: Paliperidone ER was well tolerated and associated with significantly greater improvements in symptomatology, functioning, and overall clinical status vs. placebo in patients with schizophrenia and prominent affective symptoms.