Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
Randomised, triple-blind (participant, investigator, outcomes assessor), active-placebo-controlled pilot trial (NCT02397889; Icahn School of Medicine at Mount Sinai). Participants: 30 adults with chronic PTSD. Intervention: repeated IV ketamine vs IV midazolam (active control). Status: COMPLETED. Start: May 2015. Primary results published: Feder A et al., Am J Psychiatry 2021 (PMID 33397139). Secondary neuroimaging sub-study: Danböck SK et al., Psychopharmacology 2024 (PMID 37872291) — fMRI resting-state fronto-limbic connectivity, 28 enrolled, 26 completed.
Study Arms & Interventions
Ketamine
experimentalSubanesthetic dose of ketamine administered via intravenous infusion over 40 minutes.
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
administered over 40 min
Midazolam
active comparatorControl drug midazolam administered via intravenous infusion over 40 minutes to account for subjective effects and preserve blinding.
Interventions
- Placebo0.045 mg/kgvia IV• single dose• 1 doses total
administered over 40 min
Primary Results(2 publications)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamineexperimental | 11 | — | — | — | — |
| Midazolamactive_comparator | 10 | — | — | — | — |
| Ketamineexperimental | 12 | — | — | — | 1(8.3%) |
| Midazolamactive_comparator | 14 | — | — | — | 0(0.0%) |
* No specific counts for treatment-emergent adverse events (TEAEs) were reported for this arm. The study mentions 'Drug side-effect measures' but these are changes in scores on scales, not counts of adverse events.
* One participant stopped infusion early (per CONSORT flow diagram Figure S1). No specific TEAE counts reported in text.
* No specific TEAE counts reported in text.