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.
Subanesthetic dose of ketamine administered via intravenous infusion over 40 minutes.
administered over 40 min
Control drug midazolam administered via intravenous infusion over 40 minutes to account for subjective effects and preserve blinding.
administered over 40 min