Pilot Randomized Double-Blind Placebo-Controlled Trial Protocol: Neurobion IM plus Flupentixol–Melitracen (Deanxit) for Appetite Restoration in Psychogenic Anorexia"

Psychogenic loss of appetite is a frequent yet under-investigated symptom associated with anxiety and depressive states. This protocol presents a pilot randomized, double-blind, placebo-controlled trial designed to evaluate the combined effects of a neurotropic vitamin injection (Neurobion IM: thiamine, pyridoxine, cyanocobalamin) and the fixed-dose antidepressant–anxiolytic combination flupentixol–melitracen (Deanxit) on appetite restoration. Sixty participants with psychogenic anorexia will be randomized to active treatment or placebo for four weeks. The primary endpoint is change in subjective appetite (VAS 0–10); secondary outcomes include body weight, PHQ-9, GAD-7, and safety/adverse events. Results will provide preliminary effect size estimates and feasibility data to inform the design of a definitive multicenter RCT. This work aims to generate early clinical evidence for an adjunctive pharmacological–nutraceutical strategy to restore appetite in patients with psychogenic anorexia.