Paliperidone palmitate in non-acute patients with schizophrenia previously unsuccessfully treated with risperidone long-acting therapy or frequently used conventional depot antipsychotics. (August 2015)

• Record Type: Journal Article
• Authors: Schreiner, A; Bergmans, P; Cherubin, P; Keim, S; Llorca, P-M; Cosar, B; Petralia, A; Corrivetti, G; Hargarter, L
• Is Part Of: Journal of psychopharmacology. Volume 29:Number 8(2015:Aug.)
• Page Start: 910
• Page End: 922
• Publication Date: 2015-08
• Subjects: Non-acute -- paliperidone palmitate -- schizophrenia -- switching -- injectable antipsychotic; Psychopharmacology -- Periodicals; 615.78
• DOI: 10.1177/0269881115586284
• Languages: English
• ISSNs: 0269-8811

Abstract

PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in adults ( n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs). Treatment response was measured by change in Positive and Negative Syndrome Scale (PANSS) total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events. Significant reductions in mean PANSS total score were observed for all groups (−7.5 to −10.6; p ⩽ 0.01 [BL to LOCF EP]). After switching to PP, more than 50% of all patients achieved ⩾20% and one-third of RLAT-treated patients even achieved ⩾50% improvement in PANSS total score. Across groups, there were significant improvements ( p < 0.05) in symptom severity as measured by Clinical Global Impression-Severity (CGI-S; trend for improvement with RLAT; p = 0.0568), subjective well-being, medication satisfaction, and patient functioning with PP. PP was generally well tolerated. Clinically relevant benefits were observed in non-acute patients with schizophrenia switched from RLAT or conventional depot APs to PP.