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

Abstract

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 Clin Psychiatry 2015;76(3):253-262 J

Combined Antirelapse Therapy in Patients with Schizoaffective Disorder: A Prospective Cohort Study

“…[1,14,15] Possibilities of preventive treatment expanded considerably after the introduction of mood stabilizers (MSs). [1,3,19] The preference is currently given to atypical antipsychotic medications which have a mood stabilizing effect in addition to an antipsychotic one. [16,17,20] The most frequently prescribed are second-generation antipsychotics, but the high cost and side effects (weight gain and sexual dysfunction) lead to patients with SAD abandoning treatment.…”

“…Articles dedicated to SAD treatment in the interictal period are rare. [9,20] In most studies, SAD patients are often combined into one group along with schizophrenia patients or less commonly with those suffering from affective disorders, [18][19][20] which makes it difficult to obtain data about the peculiarities of SAD treatment. Therefore, it became necessary to investigate the influence of different types of therapy on the quality of remission in schizoaffective disorder.…”

Estimated medical cost reductions for paliperidone palmitate vs placebo in a randomized, double-blind relapse-prevention trial of patients with schizoaffective disorder

“…The 15-month, randomized, double-blind, placebocontrolled, parallel-group study of paliperidone palmitate evaluating time to relapse in subjects with schizoaffective disorder investigated the efficacy, safety, and tolerability of the once-monthly, atypical, long-acting, antipsychotic, paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder 11,12 . This long-term study demonstrated that paliperidone palmitate treatment at doses of 78-234 mg significantly delayed relapse and reduced risk of relapse in patients with schizoaffective disorder 11,12 .…”

Does Indication Drive Use, or Does Use Drive Indication?

“…n this issue of The Journal of Clinical Psychiatry, Fu et al 1 report on the results of a study of paliperidone palmitate once-monthly in patients diagnosed with schizoaffective disorder. In this well-designed and well-executed trial, paliperidone monthly was used either as monotherapy or as an adjunct to mood stabilizers or antidepressants.…”

“…One of the interesting elements of Fu and colleagues' study 1 is the separation of the subjects into a group that could be treated with paliperidone monthly alone and a group who were already established prestudy on mood stabilizers and antidepressants and were allowed to remain on them. The investigators understood that schizoaffective disorder is often treated with multiple drugs.…”