Clinical TrialParallelKetamineKetaminePlaceboCompleted

CAP-Ketamine for Antidepressant Resistant PTSD

The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an active duty military and Veteran population.

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Target Enrollment
Not specified
Study Type
Phase II interventional
Design
Randomized

Study Arms & Interventions

Standard Dose

experimental

Ketamine 0.5 mg/kg administered via 8 intravenous infusions, twice weekly.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice weekly• 8 doses total

    8 infusions total

Low Dose

experimental

Ketamine 0.2 mg/kg administered via 8 intravenous infusions, twice weekly.

Interventions

  • Ketamine0.2 mg/kg
    via IV• twice weekly• 8 doses total

    8 infusions total

Placebo

placebo

Intravenous placebo (normal saline) administered twice weekly.

Interventions

  • Placebo
    via IV• twice weekly• 8 doses total

    normal saline

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomized
  • Timeline
    Start: 2016-04-18
    End: 2020-07-01
  • Compounds
    KetamineKetaminePlacebo

Study Team

Sponsors & Collaborators

Related Publications

Open AccessindividualPrimary

Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial

This double-blind RCT (n=158) assessed 8 repeated doses of intravenous ketamine administered twice weekly at a low dose (0.2 mg/kg; n = 53), standard dose (0.5 mg/kg; n = 51) ketamine or placebo (n=54) in veterans and service members with PTSD. It was found that the standard dose of ketamine reduced MADRS scores significantly more than placebo. However, the trial failed to find a significant dose-related effect of ketamine on PTSD symptoms measured using the CAPS-5.

Published
Journal
Neuropsychopharmacology
Authors
Abdallah, C. G., Roache, J. D., Gueorguieva, R., Averill, L. A., Young-McCaughan, S., Shiroma, P. R., Purohit, P., Brundige, A., Murff, W., Ahn, K-H., Baltutis, E. J., Ranganathan, M., D’Souza, D. C., Souza, S. E., Martini, B., Southwick, S. M., Burson, R. R., Guthmiller, K. B., McCallin, J. P., Hoch, M. B., Timchenko, A., Bryant, C. E., Mintz, J., Williamson, D. E., Keane, T. M., Peterson, A. L., Krystal, J. H.

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