Single IV Ketamine vs Midazolam for TRD with Suicidal Ideation: dPFC Volumetric RCT (Li WC / Su TP / Li CT, TVGH Taiwan)
Double-blind parallel RCT of single IV ketamine vs active midazolam control, with dPFC volumetric MRI as primary outcome (J Affect Disord 2023 Aug; Li WC, Chen LF, Su TP, Li CT, Lin WC et al.; Taipei Veterans General Hospital, Taiwan; PMID 37178823). n=48 randomised; participants: TRD (failed ≥2 adequate antidepressant trials) with active suicidal ideation; unipolar MDD. Intervention: single IV infusion of ketamine 0.5 mg/kg over 40 min vs midazolam 0.045 mg/kg active control. MRI-based dorsolateral/dorsal prefrontal cortex (dPFC/DLPFC) volumetric analysis at baseline and follow-up. MADRS, suicidal ideation scales as secondary outcomes. No CT.gov registration; no registration number reported in methods. CT.gov reverse-lookup (PMID, and author+condition search): 0 hits.
Study Arms & Interventions
Ketamine
experimentalSingle IV infusion of low-dose ketamine
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
Low-dose ketamine infusion
Midazolam
active comparatorSingle IV infusion of midazolam
Interventions
- Placebo0.045 mg/kgvia IV• single dose• 1 doses total
Midazolam used as a control condition due to similar pharmacokinetic characteristics
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamineexperimental | 24 | — | — | — | — |
| Midazolamactive_comparator | 24 | — | — | — | — |
* No adverse event data was reported for this arm.