Dose-Related Effects of Single IV Ketamine Infusion in Treatment-Resistant Depression: A Randomised Parallel-Group Trial (Su 2017, Taipei Veterans General Hospital)
Double-blind, randomised, parallel-group, placebo-controlled trial (Neuropsychopharmacology 2017; Su TP, Chen MH, Li CT, ..., Krystal JH; Taipei Veterans General Hospital + National Yang-Ming University, Taipei, Taiwan). Participants: 74 enrolled, 71 analysed; recurrent major depressive disorder (MDD), failed ≥2 adequate antidepressant trials; BDNF genotyped (Val/Val, Val/Met, Met/Met). Three arms: (1) IV saline placebo; (2) single IV ketamine 0.2 mg/kg; (3) single IV ketamine 0.5 mg/kg. Hamilton Depression Rating Scale (HAMD) assessed before infusion, after infusion, and over 14 days. Plasma ketamine and BDNF levels measured. Conducted 2012–2015. No CT.gov or Taiwanese registry number found (PubMed DataBankList empty).
Study Arms & Interventions
0.5mg/kg Ketamine
experimentalSingle 40 min intravenous infusion of R/S-ketamine hydrochloride at 0.5 mg/kg
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
R/S-ketamine hydrochloride
0.2mg/kg Ketamine
experimentalSingle 40 min intravenous infusion of R/S-ketamine hydrochloride at 0.2 mg/kg
Interventions
- Ketamine0.2 mg/kgvia IV• single dose• 1 doses total
R/S-ketamine hydrochloride
Placebo (normal saline)
placeboSingle 40 min intravenous infusion of normal saline
Interventions
- Placebovia IV• single dose• 1 doses total
Normal saline
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| 0.5mg/kg Ketamineexperimental | 24 | — | — | — | — |
| 0.2mg/kg Ketamineexperimental | 23 | — | — | — | — |
| Placebo (normal saline)placebo | 24 | — | — | — | — |
* The paper mentions nausea occurred in 6 patients (8.5% of the sample) but does not provide a breakdown of nausea by specific arm.