Citation

Turkoz I, Fu DJ, Bossie CA, Alphs L. Innov. Clin. Neurosci. 2015; 12(11-12): 10-17.

Copyright

(Copyright © 2015, Matrix Medical Communications)

DOI

unavailable

PMID

unavailable

Abstract

BACKGROUND: This analysis evaluates improvement in symptoms of depression in patients with schizoaffective disorder administered oral paliperidone extended-release by accounting for the magnitude of direct and indirect (changes in negative and positive symptoms and worsening of extrapyramidal symptoms) treatment effects on depressive symptoms.

METHODS: Data for this post hoc analysis were drawn from two sixweek, randomized, placebocontrolled studies of paliperidone extended-release versus placebo in adult subjects with schizoaffective disorder (N=614; NCT00412373, NCT00397033). Subjects with baseline 17-item Hamilton Rating Scale for Depression scores of 16 or greater were included. Structural equation models (path analyses) were used to separate total effects into direct and indirect effects on depressive symptoms. Change from baseline in 17-item Hamilton Rating Scale for Depression score at the Week 6 end point was the dependent variable; changes in Positive and Negative Syndrome Scale positive and negative factors and Simpson-Angus Scale (to evaluate extrapyramidal symptoms) scores were independent variables.

RESULTS: At baseline, 332 of 614 (54.1%) subjects had a 17-item Hamilton Rating Scale for Depression score of 16 or greater. Path analysis determined that up to 26.4 percent of the paliperidone extended-release versus placebo effect on depressive symptoms may be attributed to a direct treatment effect, and 45.8 percent and 28.4 percent were mediated indirectly through improvements on positive and negative symptoms, respectively. No effects were identified as mediated through extrapyramidal symptoms changes (-0.7%).

CONCLUSION: Results of this analysis suggest that paliperidone's effect on depressive symptoms in subjects with schizoaffective disorder participating in two sixweek, randomized, placebocontrolled studies is mediated through indirect effects (e.g., positive and negative symptom changes) and a direct treatment effect. © 2015, Matrix Medical Communications. All rights reserved.

Language: en

Keywords

adult; human; female; male; depression; Depressive symptoms; randomized controlled trial; suicide attempt; disease severity; Path analysis; controlled study; placebo; health care personnel; extrapyramidal symptom; schizoaffective psychosis; DSM-IV; Schizoaffective disorder; Article; Positive and Negative Syndrome Scale; nerve cell differentiation; path analysis; paliperidone; Paliperidone; Direct effects