Psychiatry research · 2026
Cytokine changes during a 12-month pragmatic randomized trial in schizophrenia spectrum disorders comparing amisulpride, aripiprazole and olanzapine.
Сравнительное исследованиеСтатьяPragmatic Clinical TrialРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Kroken Rune Andreas, Johnsen Erik, Alisauskiene Renata, Anda Liss Gøril, Bartz-Johannesen Christoffer, Berle Jan Øystein, Bjarke Jill, Bruserud Øystein, Fathian Farivar, Fleischhacker W Wolfgang, Hugdahl Kenneth, Joa Inge, Kjelby Eirik, Larsen Tor Ketil, Løberg Else-Marie, Ratke Ieva, Rettenbacher Maria, Sinkeviciute Igne, Skrede Silje, Stabell Lena, Steen Vidar Martin, Torsvik Anja, Reitan Solveig Klæbo
Аннотация
BACKGROUND: Schizophrenia is associated with inflammation. Antipsychotic drugs have anti-inflammatory properties but few antipsychotics have been compared head-to head. The aim of this study was to evaluate the immunomodulatory effects of three pharmacologically different atypical antipsychotics, amisulpiride, aripiprazole and olanzapine, in patients with schizophrenia-spectrum disorders.
METHODS: The study reports a predefined secondary outcome of the BeSt InTro-study, a double blind randomized head-to-head trial comparing amisulpride, aripiprazole and olanzapine. Patients with a schizophrenia-spectrum disorder (N=144) were randomized to the different treatment arms, and serum levels of nine cytokines (interleukin [IL]-1β, IL-2, IL-4, IL-6, IL-10, IL-12p70, IL-17A, interferon [IFN]-γ, and tumor necrosis factor [TNF]-α) were assessed at baseline and weeks 1, 3, 6, 12, 26, 39 and 52. A combined pro-inflammatory variable was constructed from IL1-β and TNF-α. The primary analyses were done in per protocol (PP) data in the drug-naïve sample (n = 56). Changes in cytokine levels between baseline and the end of the study were analyzed in a mixed effects model with amisulpride as the reference drug.
RESULTS: Treatment with amisulpride was associated with a reduction in pro-inflammatory IL-1β levels over 12 months, this change was statistically different compared to the change in aripiprazole and olanzapine. A significant difference between the influence of amisulpride compared to aripiprazole on the anti-inflammatory cytokine IL-10 was detected. Aripiprazole reduced IL-12p70 more than amisulpride. The combined pro-inflammatory variable decreased from baseline to week 52 with a magnitude of 0.52 standard deviation (SD) after treatment with amisulpride..
CONCLUSION: Patients treated with amisulpride showed greater anti-inflammatory changes in cytokine serum levels than those treated with aripiprazole or olanzapine.
FUNDING: The Research Council of Norway, the Western Norway Regional Health Trust, and Klinbeforsk supported the study.
METHODS: The study reports a predefined secondary outcome of the BeSt InTro-study, a double blind randomized head-to-head trial comparing amisulpride, aripiprazole and olanzapine. Patients with a schizophrenia-spectrum disorder (N=144) were randomized to the different treatment arms, and serum levels of nine cytokines (interleukin [IL]-1β, IL-2, IL-4, IL-6, IL-10, IL-12p70, IL-17A, interferon [IFN]-γ, and tumor necrosis factor [TNF]-α) were assessed at baseline and weeks 1, 3, 6, 12, 26, 39 and 52. A combined pro-inflammatory variable was constructed from IL1-β and TNF-α. The primary analyses were done in per protocol (PP) data in the drug-naïve sample (n = 56). Changes in cytokine levels between baseline and the end of the study were analyzed in a mixed effects model with amisulpride as the reference drug.
RESULTS: Treatment with amisulpride was associated with a reduction in pro-inflammatory IL-1β levels over 12 months, this change was statistically different compared to the change in aripiprazole and olanzapine. A significant difference between the influence of amisulpride compared to aripiprazole on the anti-inflammatory cytokine IL-10 was detected. Aripiprazole reduced IL-12p70 more than amisulpride. The combined pro-inflammatory variable decreased from baseline to week 52 with a magnitude of 0.52 standard deviation (SD) after treatment with amisulpride..
CONCLUSION: Patients treated with amisulpride showed greater anti-inflammatory changes in cytokine serum levels than those treated with aripiprazole or olanzapine.
FUNDING: The Research Council of Norway, the Western Norway Regional Health Trust, and Klinbeforsk supported the study.