A Randomized, Double-Blind, Placebo-Controlled Study of 2 Dose Ranges of Paliperidone Extended-Release in the Treatment of Subjects With Schizoaffective Disorder

Abstract

clincaltrials.gov Identifier: NCT00397033.

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

“…These results support prior evidence that the paliperidone molecule is effective and safe for acute management of these schizoaffective disorder symptoms following relapse. 5,6 The efficacy of paliperidone monthly monotherapy suggests that it may serve as a foundation for treatment of patients with schizoaffective disorder. As monotherapy, paliperidone monthly eliminates requirements for simultaneous management of multiple psychotropic medications for physicians and daily oral medication adherence by patients.…”

“…3 Like schizophrenia, onset of schizoaffective disorder is typically in early adulthood; however, consistent diagnosis usually occurs several years following initial recognition of psychiatric illness. [4][5][6][7] Persons with schizoaffective disorder experience significant functional impairment 4,8 and higher rates of hospitalization, suicidality, and substance abuse than persons with schizophrenia. 9 Optimal management of schizoaffective disorder requires long-term treatment, and its prognosis is intermediate to that of schizophrenia and affective disorders.…”

“…22 Long-acting injectable therapies, such as once-monthly paliperidone palmitate (paliperidone monthly), provide consistent therapeutic plasma concentrations over several weeks, eliminating the need for daily oral medication and facilitating monitoring of treatment adherence. 23,24 Building on efficacy data of oral paliperidone in acute management of schizoaffective disorder, 5,6 this relapse-prevention study was designed to compare paliperidone monthly given as monotherapy or with adjunctive antidepressants or mood stabilizers to placebo in patients with schizoaffective disorder.…”

“…4,8,10,11 To manage psychotic, depressive, and manic symptoms, schizoaffective disorder is treated with complex pharmacologic regimens that include antipsychotics, mood stabilizers, and antidepressants. [12][13][14] Only oral paliperidone, administered as monotherapy or adjunctively with mood stabilizers and/or antidepressants, has received regulatory approval for acute treatment of schizoaffective disorder [5][6][7]15 ; however, no widely accepted clinical guidelines for acute or maintenance treatment exist.…”

Neuropsychological and Brain Functional Changes Across the Different Phases of Schizoaffective Disorder

“…Clear evidence of efficacy and tolerability exists for just a few atypical antipsychotics, mainly paliperidone (Canuso et al, 2010) and risperidone (Janicak et al, 2001). Evidence from large schizophrenia trials that have included a subset of patients with schizoaffective disorder also supports the effectiveness of aripiprazole, olanzapine and ziprasidone (Murru et al, 2011).…”