Clinical TrialKetamineKetaminePlaceboCompleted

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.

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

Primary Results(1 publication)

Participants

N = 158Mean age: 42–45.2 across armsG. et al. 2022 →

PCL-5

Score at Timepoint

Standard Dose—Day 28·G. et al. 2022 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Standard Doseexperimental5146(90.2%)———
Low Doseexperimental5346(86.8%)———
Placeboplacebo5445(83.3%)———

* Based on Table S1: # Subjects Reporting 46. Total AEs reported was 138.

* Based on Table S1: # Subjects Reporting 46. Total AEs reported was 154.

* Based on Table S1: # Subjects Reporting 45. Total AEs reported was 110.

Study Details

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

Related Publications

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

Published
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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