The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry · 2026
Sexual function despite hyperprolactinemia: a 24-month analysis of paliperidone palmitate versus haloperidol decanoate.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Serretti Alessandro
Аннотация
OBJECTIVES: Sexual dysfunction is common in schizophrenia and may contribute to poor quality of life and non-adherence. Paliperidone palmitate (PP) and haloperidol decanoate (HD) differ substantially in prolactin liability, but their long-term effects on sexual function are unclear. We compared 24-month ASEX trajectories and prolactin-ASEX associations in the ACLAIMS trial.
METHODS: In participants with ≥1 ASEX assessment, ASEX total score (5-30) was modelled longitudinally with mixed-effects models for repeated measures (MMRM); the binary sexual-dysfunction outcome was modelled with generalised estimating equations (GEE). Prolactin was assessed from months -0.5-24, and prolactin-ASEX associations were examined by sex.
RESULTS: 175 participants were included (PP n = 86; HD n = 89). Baseline dysfunction prevalence was 49% in both arms. PP produced higher prolactin throughout follow-up (all p<.001), but ASEX trajectories did not differ significantly. An exploratory month 22-24 window comparison favoured PP (p=.019). Greater prolactin rise from baseline was associated with overall ASEX worsening at month 12 (r = 0.21, p=.013), with concordant but non-significant sex-specific estimates (males r = 0.15; females r = 0.30).
CONCLUSION: Despite higher prolactin with PP, ASEX trajectories were similar between PP and HD. A late PP-favouring signal was observed. Greater within-person prolactin increase was associated with later sexual-function worsening across the cohort.
METHODS: In participants with ≥1 ASEX assessment, ASEX total score (5-30) was modelled longitudinally with mixed-effects models for repeated measures (MMRM); the binary sexual-dysfunction outcome was modelled with generalised estimating equations (GEE). Prolactin was assessed from months -0.5-24, and prolactin-ASEX associations were examined by sex.
RESULTS: 175 participants were included (PP n = 86; HD n = 89). Baseline dysfunction prevalence was 49% in both arms. PP produced higher prolactin throughout follow-up (all p<.001), but ASEX trajectories did not differ significantly. An exploratory month 22-24 window comparison favoured PP (p=.019). Greater prolactin rise from baseline was associated with overall ASEX worsening at month 12 (r = 0.21, p=.013), with concordant but non-significant sex-specific estimates (males r = 0.15; females r = 0.30).
CONCLUSION: Despite higher prolactin with PP, ASEX trajectories were similar between PP and HD. A late PP-favouring signal was observed. Greater within-person prolactin increase was associated with later sexual-function worsening across the cohort.