Adjunctive aripiprazole for amisulpride-induced hyperprolactinemia: a preliminary retrospective study showing no reversing effect
Abstract
Background: The potential of aripiprazole to reverse amisulpride-induced hyperprolactinemia has yet to be established.
Objectives: To investigate whether adjunctive aripiprazole treatment can reverse amisulpride-induced prolactin (PRL) elevation.
Design: This study was a single-arm retrospective cohort study.
Methods: We conducted a retrospective analysis of medical records from patients treated with amisulpride at a tertiary specialized psychiatric hospital, between June 1, 2022, and December 31, 2025, who subsequently received adjunctive aripiprazole. Data were collected via the electronic medical record system. A paired t-test was used to compare PRL values before (⩽7 days, PRL1) and after (⩾7 days, PRL2) aripiprazole initiation.
Results: The difference between PRL1 and PRL2 was not statistically significant (mean difference = 4.115 ng/ml, 95% CI (-5.121, 13.351) ng/ml, SD = 15.284, p = 0.351, Cohen's d = 0.269, 95% CI for d (-0.290, 0.818)). Stratified analyses by sex and diagnosis yielded results consistent with the main analysis across subgroups (p > 0.05). None of the leave-one-out analyses altered the study's conclusions (all p-values > 0.05), indicating that the results were not driven by any single extreme value.
Conclusion: In individuals with amisulpride-related hyperprolactinemia, this retrospective study suggests that adjunctive aripiprazole has an insignificant therapeutic effect in reversing PRL elevation. Therefore, until more comprehensive research evidence…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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