Safety Study of Riluzole to Treat Post-traumatic Stress Disorder (PTSD)

Phase 1/2 Completed 75 enrolled Uniformed Services University of the Health Sciences U.S. Army Medical Research and Development Command · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether Riluzole is effective in the augmentation treatment of post-traumatic stress disorder (PTSD) that is experienced by Active Duty military service members and Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) veterans who have not had symptom reduction after one or more kinds of medications or therapies.

Timeline

Start: 2013-07
Primary completion: 2017-10-30
Completion: 2017-11-30

Outcome

Missed primary endpoint

registry analysis (superiority test); Riluzole vs Placebo; p = 0.442; ANCOVA NCT02155829 ↗

Publications

Spangler PT, West JC, Dempsey CL, Possemato K, Bartolanzo D, Aliaga P, Zarate C, Vythilingam M, Benedek DM. Randomized Controlled Trial of Riluzole Augmentation for Posttraumatic Stress Disorder: Efficacy of a Glutamatergic Modulator for Antidepressant-Resistant Symptoms. J Clin Psychiatry. 2020 Oct 27;81(6):20m13233. doi: 10.4088/JCP.20m13233.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Riluzole	Small molecule	200 mg	Oral