Low-Dose Ketamine Effects on PFC and Amygdala in TRD: Double-Blind 3-Arm RCT with FDG-PET (Li CT / Su TP, TVGH Taiwan; UMIN000016985)

Double-blind, randomized, placebo-controlled 3-arm trial of low-dose IV ketamine in TRD with FDG-PET neuroimaging (Hum Brain Mapp 2016 Mar; Li CT, Chen MH, Lin WC, Hong CJ, Yang BH, Liu RS; Taipei Veterans General Hospital, Taiwan; PMID 26821769; DOI 10.1002/hbm.23085; UMIN000016985 confirmed via PubMed DataBankList). n=48 adults (aged 21–65) meeting DSM-IV-TR MDD criteria with TRD (failed ≥3 antidepressants including one during the current episode); background medications continued (add-on design). Randomised 1:1:1 to: Group A – ketamine 0.5 mg/kg IV over 40 min; Group B – ketamine 0.2 mg/kg IV over 40 min; Group C – normal saline. 16 subjects per arm. Primary outcome: FDG-PET-derived PFC and amygdala standardised uptake values (SUVs) pre- and post-infusion. HDRS-17 at baseline and 40/80/120/240 min post-infusion. Responder = ≥50% HDRS-17 reduction. BPRS positive subscale and side-effect monitoring for safety. UMIN000016985 registry confirmed.