Evaluating the Effectiveness of Cyproheptadine on Acute Neuroleptic-induced Akathisia

BACKGROUND: Akathisia is among the most common and distressing side effects of antipsychotic medications, adversely affecting treatment adherence and clinical outcomes. This study aimed to evaluate the effectiveness of cyproheptadine compared with placebo in treating acute neuroleptic-induced akathisia. METHODS: This double-blind, randomized controlled trial enrolled patients hospitalized in psychiatric units who were diagnosed with neuroleptic-induced akathisia and met the inclusion criteria. Fifty patients (25 per group) were included based on the anticipated effect size [a 0.5-point change on the Barnes Akathisia Rating Scale (BARS)]. The intervention group received cyproheptadine at a dose of 4 mg every 12 hours. Akathisia symptoms were evaluated using the BARS, assessing objective, subjective, distress, and global akathisia scores at baseline and on days 4 and 7 postintervention. The minimum BARS score required for study entry was 2. Data analysis was performed using STATA software version 14. RESULTS: The intervention and control groups were homogeneous regarding sex distribution ( P =1), age ( P =0.393), and antipsychotic medications used ( P =0.493). Repeated-measures ANOVA revealed a significant reduction in BARS scores over time in the intervention group compared with the placebo group on days 4 and 7 postintervention ( P