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A Pilot Study of Riluzole in Patients with PTSD

This study is not currently enrolling participants

Introduction

PTSD is a debilitating and chronic psychiatric disorder with limited treatment options. Currently, there are only two FDA-approved medications to treat PTSD and both are monoaminergic antidepressants (SSRIs specifically). There are high rates of non-response or partial response to these medications. Thus, there is urgent need to explore other medications that may be effective in reducing symptoms of PTSD.

Riluzole is an FDA-approved medication for Amyotrophic Lateral Sclerosis (ALS), which is also known as Lou Gehrig’s Disease. Preclinical animal studies have shown riluzole to modulate glutamate release and clearance, and to have potent neuroprotective properties, promoting neuro-resilience. Other preclinical data also show the drug to have anxiolytic-like (anti-anxiety) and antidepressant-like effects in rodent models of stress. In addition, several open-label clinical studies further suggest riluzole has anxiolytic and antidepressant properties, even in patients who do not respond to standard monoaminergic antidepressant and anxiolytic medications. However, to date, riluzole has not been studied in patients suffering from PTSD. The proposed study will provide pilot data on the efficacy of riluzole in PTSD. An optional component of this study will investigate the mechanisms underlying its effect on the brain by using advanced magnetic resonance imaging and spectroscopy methods.

This is a 12-week open-label trial. All study participants will receive the active drug. Participants will be asked to take the medication daily over a 12-week period and will attend a once-weekly brief visit to monitor for symptom changes, side-effects, and adverse events.