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.
Study Arms & Interventions
Ketamine 0.5mg/kg
experimental40-min intravenous infusion of 0.5 mg/kg ketamine
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
40-min constant intravenous infusion
Ketamine 0.2mg/kg
experimental40-min intravenous infusion of 0.2 mg/kg ketamine
Interventions
- Ketamine0.2 mg/kgvia IV• single dose• 1 doses total
40-min constant intravenous infusion
Placebo
placebo40-min intravenous infusion of normal saline
Interventions
- Placebovia IV• single dose• 1 doses total
normal saline infusion
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamine 0.5mg/kgexperimental | 16 | 15(93.8%) | 0(0.0%) | 0(0.0%) | — |
| Ketamine 0.2mg/kgexperimental | 16 | 3(18.8%) | 0(0.0%) | 0(0.0%) | — |
| Placeboplacebo | 16 | 3(18.8%) | 0(0.0%) | 0(0.0%) | — |
* TEAEs are summed from specific side effects reported in Table II: Floating Sensations (8), Dissociation (1), Dizziness/Nausea (2), Chest tightness (2), Others (Crying) (2). All side effects were reported as mild and self-limiting, requiring no additional medical treatment, indicating no severe or serious TEAEs.
* TEAEs are summed from specific side effects reported in Table II: Floating Sensations (1), Dizziness/Nausea (1), Chest tightness (1). All side effects were reported as mild and self-limiting, requiring no additional medical treatment, indicating no severe or serious TEAEs.
* TEAEs are summed from specific side effects reported in Table II: Dizziness/Nausea (2), Others (Crying) (1). All side effects were reported as mild and self-limiting, requiring no additional medical treatment, indicating no severe or serious TEAEs.