Paliperidone palmitate once-monthly reduces risk of relapse of psychotic,
depressive, and manic symptoms and maintains functioning in a double-blind,
randomized study of schizoaffective disorder.
Author(s): Fu DJ(1), Turkoz I, Simonson RB, Walling DP, Schooler NR, Lindenmayer JP, Canuso
CM, Alphs L.
Affiliation(s): Author information:
(1)Clinical Development, Janssen Scientific Affairs, 1125 Trenton-Harbourton Rd,
Titusville, NJ 08560 dfu@its.jnj.com.
Publication date & source: 2015, J Clin Psychiatry. , 76(3):253-62
OBJECTIVE: Schizoaffective disorder is a complex illness for which optimal
treatment is not well established. Results of the first controlled,
relapse-prevention study of paliperidone palmitate once-monthly injectable
(paliperidone monthly) in schizoaffective disorder are presented.
METHOD: The study was conducted between September 20, 2010, and October 22, 2013.
Patients with schizoaffective disorder (confirmed by the Structured Clinical
Interview for DSM-IV Axis I Disorders) experiencing acute exacerbation of
psychotic and depressive/manic symptoms were stabilized with paliperidone monthly
as monotherapy or as adjunctive therapy to mood stabilizers or antidepressants
and randomly assigned (1:1) to paliperidone monthly or placebo in a 15-month,
double-blind, relapse-prevention phase. Randomization was stratified by
administration as monotherapy or adjunctive therapy and by study center. The
primary endpoint was time to relapse.
RESULTS: 334 patients were evaluated. Paliperidone monthly significantly delayed
time to relapse for psychotic, depressive, and manic symptoms compared with
placebo (P < .001, log-rank test). Relapse risk was 2.49 times greater for
placebo (hazard ratio = 2.49; 95% CI, 1.55 to 3.99; P < .001, Cox proportional
hazards model). Overall relapse rates were 33.5% for placebo and 15.2% for
paliperidone monthly. For monotherapy, relapse risk was 3.38 times greater with
placebo (P = .002), and for adjunctive treatment it was 2.03 times greater with
placebo (P = .021). Paliperidone monthly was superior to placebo in maintaining
functioning as measured by the Personal and Social Performance scale (P = .014,
mixed-model repeated-measures analysis). The most common adverse events (placebo,
paliperidone monthly) were increased weight (4.7%, 8.5%), insomnia (7.1%, 4.9%),
schizoaffective disorder (5.9%, 3.0%), headache (3.5%, 5.5%), and nasopharyngitis
(3.5%, 5.5%). Incidence of any extrapyramidal-related adverse event was 7.1% for
placebo and 8.5% for paliperidone monthly.
CONCLUSIONS: Paliperidone monthly as monotherapy or adjunctive therapy
significantly delayed psychotic, depressive, and/or manic relapses; reduced their
risk; and better maintained functioning in patients with schizoaffective
disorder. Results support the value of maintenance treatment with paliperidone
monthly in schizoaffective disorder.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01193153.
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