Safety and efficacy of high-dose vitamin B6 for treating antipsychotic-induced hyperprolactinemia in male patients with treatment-resistant schizophrenia

Abstract

Background and Purpose: This study aimed to investigate the safety and\nefficacy of high-dose vitamin B6 (vB6) for antipsychotic-induced\nhyperprolactinemia (AIHP) treatment in male patients with\ntreatment-resistant schizophrenia (TRS). Experimental Approach: In this\nrandomized double-blinded controlled study, patients were randomized\n(1:1) into a control group given aripiprazole (ARI; 10 mg/day) or an\nintervention group given vB6 (300 mg/12 h for 16 weeks). Prolactin\nlevel, psychotic symptoms [Positive and Negative Syndrome Scale\n(PANSS)], cognitive function [MATRICS Consensus Cognitive Battery\n(MCCB)], liver function, kidney function, growth hormone level,\nmicronutrient levels, blood lipids, and adverse secondary effects\n(ASEs)[Treatment Emergent Symptom Scale (TESS) and Barnes-Akathisia\nscale] were monitored. Key Results: After a 16-week treatment period,\nthe vB6 group showed a 68.1% reduction in serum prolactin levels (from\n95.52 ± 6.30 μg/L to 30.43 ± 18.65 μg/L) while the ARI group showed only\na 37.4% reduction (from 89.07 ± 3.59 μg/L to 55.78 ± 7.39 μg/L). During\nweeks 1–4, both treatments reduced prolactin similarly. Subsequently,\nthe ARI effect plateaued, while the vB6 effect remained robust. AIHP\nreduction efficacy of vB6 was associated with baseline prolactin and\ntriglyceride levels, total vB6 dosage, and education level. Conclusion\nand Implications: Compared with the ARI group, TRS patients given vB6\nshowed better attenuation of AIHP, lower ASE scores, and improvements in\nclinical symptoms and cognitive impairments. These results support\nfurther consideration of vB6 as a putative treatment for AIHP.