title: Paliperidone extended-release in schizoaffective disorder: a randomized, controlled study comparing a flexible dose with placebo in patients treated with and without antidepressants and/or mood stabilizers.
abstract: This 6-week, double-blind, placebo-controlled study evaluated paliperidone extended-release (ER) as both monotherapy and adjunctive therapy to mood stabilizers and/or antidepressants (MS/ADs) for schizoaffective disorder. Included subjects had a schizoaffective disorder diagnosis; a Positive and Negative Syndrome Scale (PANSS) total score of 60 or higher; a score of 4 or higher on 2 or more of the PANSS items for hostility, excitement, tension, uncooperativeness, or poor impulse control; and prominent mood symptoms (≥16 on the Young Mania Rating Scale and/or the 21-item Hamilton Rating Scale for Depression). Subjects were randomized to 6 mg/d paliperidone ER or placebo with flexible dosing (3-12 mg/d) until day 15. Randomization was stratified by use of MS/AD and study site. The primary analysis outcome was change in PANSS total score at week 6 last observation carried forward end point. A total of 311 subjects received paliperidone ER (n = 216) or placebo (n = 95); 52.0% received MS/AD. The mean (SD) modal dose of paliperidone ER was 8.6 (2.5) mg/d. Greater improvement was observed with paliperidone ER than placebo on mean (SE) PANSS total scores: -20.0 (1.3) and -10.8 (1.9), respectively. Subjects with prominent manic or depressive symptoms showed greater improvement with paliperidone ER versus placebo: mean (SE) Young Mania Rating Scale (-10.6 [0.9] vs -5.7 [1.2], respectively) and 21-item Hamilton Rating Scale for Depression (-10.2 [0.7] vs -6.2 [1.1], respectively). The most common adverse events with paliperidone ER were headache, akathisia, dizziness, insomnia, and dyspepsia. Paliperidone ER improved psychotic and affective symptoms both as monotherapy and as an adjunct to MS/AD. No new safety findings were observed in this population.
authors.affiliation: Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ, USA. CCanuso@its.jnj.com
authors.forename: Carla M
authors.initials: CM
authors.lastname: Canuso
authors.forename: Nina
authors.initials: N
authors.lastname: Schooler
authors.forename: Jennifer
authors.initials: J
authors.lastname: Carothers
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Turkoz
authors.forename: Colette
authors.initials: C
authors.lastname: Kosik-Gonzalez
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Bossie
authors.forename: David
authors.initials: D
authors.lastname: Walling
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lindenmayer
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects*; D000928:Antidepressive Agents / Q000008:administration & dosage*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate; D011618:Psychotic Disorders / Q000188:drug therapy* / Q000523:psychology*; D011743:Pyrimidines / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D003692:Delayed-Action Preparations; D007555:Isoxazoles; D011743:Pyrimidines; D000068882:Paliperidone Palmitate