Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial

Apr 19, 2019Contemporary clinical trials

Repeated ketamine infusions for PTSD that does not respond to antidepressants: Methods of a large, controlled clinical trial

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Abstract

Approximately 198 eligible participants with PTSD will be randomized to receive either ketamine or placebo in a trial assessing the drug's efficacy.

There are currently only two FDA-approved medications for PTSD, both serotonergic antidepressants.
Pilot evidence suggests ketamine may be safe and potentially useful for treating PTSD.
The efficacy of ketamine for PTSD has not been previously tested in military or veteran populations.
This study is a multisite, placebo-controlled, double-blind, randomized clinical trial.
The trial aims to evaluate the dose-related efficacy of ketamine in reducing PTSD symptoms over an 8-week period.

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Posttraumatic stress disorder (PTSD) is a debilitating disorder with limited medication treatment options. Recent reports have described the dearth of research on new drug development as a crisis in the pharmacotherapy of PTSD. There are only two PTSD medications approved by the U.S. Food and Drug Administration, and both are serotonergic antidepressants. Therefore, there is a tremendous need to identify more effective and more rapidly acting pharmacotherapies for PTSD that work through novel neural mechanisms. Pilot evidence and case reports provided preliminary evidence supporting the safety and utility of investigating the therapeutic effects of ketamine in PTSD. However, the efficacy of this drug for PTSD has not yet been tested in active duty military or veteran populations. Here, we report the design and methods of a study funded under the Consortium to Alleviate PTSD. The study is a multisite, placebo-controlled, double-blind, randomized clinical trial to examine the dose-related efficacy of ketamine, as compared to placebo, in producing a rapid and sustained reduction in PTSD symptomatology in veterans and active duty military populations with antidepressant-resistant PTSD. Approximately 198 eligible participants who meet criteria for PTSD will be randomized to the study drug (i.e., ketamine 0.5 mg/kg, ketamine 0.2 mg/kg, or placebo). The study drug will be administered intravenously twice per week for 4 weeks, followed by a 4-week follow-up period. This ongoing study is the only trial of therapeutic effects of ketamine for PTSD and the first placebo-controlled trial to determine the dose-related effects of repeated ketamine on PTSD.

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Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial

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