Clinical TrialKetaminePlaceboCompleted

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.

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Target Enrollment
30 participants
Study Type
interventional
Design
Randomized, triple Blind

Study Arms & Interventions

Ketamine

experimental

Subanesthetic dose of ketamine administered via intravenous infusion over 40 minutes.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    administered over 40 min

Midazolam

active comparator

Control drug midazolam administered via intravenous infusion over 40 minutes to account for subjective effects and preserve blinding.

Interventions

  • Placebo0.045 mg/kg
    via IV• single dose• 1 doses total

    administered over 40 min

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2015-05-18
  • Compounds
    KetaminePlacebo

Related Publications

PaywallindividualSecondary analysis

Neuroimaging correlates and predictors of response to repeated-dose intravenous ketamine in PTSD: preliminary evidence

This preregistered randomised double-blind active placebo-controlled between-subjects study (n=21) measured brain activity while viewing facial stimuli in response to repeated and acute administration of ketamine (35mg/70kg) and midazolam (3.15mg/70kg), among patients with severe PTSD. Both midazolam and ketamine improved symptoms, which were most reliably predicted by the reduced excitation of the amygdala and ventromedial prefrontal cortex (vmPFC) during the processing of socio-emotional threat signals, but only ketamine-related improvement was associated with increased top-down inhibition of the amygdala by the vmPFC.

Published
Journal
Neuropsychopharmacology
Authors
Norbury, A., Rutter, S. B., Collins, A. B., Costi, S., Jha, M. K., Horn, S. R., Kautz, M., Corniquel, M., Collins, K. A., Glasgow, A. M., Brallier, J., Shin, L. M., Charney, D. S., Murrough, J. W., Feder, A.
Open AccessindividualPrimary

Effects of a dissociative drug on fronto-limbic resting-state functional connectivity in individuals with posttraumatic stress disorder: a randomized controlled pilot study

In a randomised controlled pilot study of 26 individuals with PTSD, subanesthetic ketamine (vs midazolam) did not increase resting‑state functional connectivity between the amygdala and medial prefrontal cortex subregions. Instead, ketamine induced a transient decrease in vmPFC–amygdala connectivity, challenging prior correlational links between dissociation and fronto‑limbic overconnectivity.

Published
Journal
Psychopharmacology
Authors
Danböck, S. K., Duek, O., Ben-Zion, Z., Korem, N., Amen, S. L., Kelmendi, B., Wilhelm, F. H., Levy, I., Harpaz-Rotem, I.