Safety Study of Riluzole to Treat Post-traumatic Stress Disorder (PTSD)
Condition: PTSD
MeSH terms: Stress Disorders, Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      Riluzole is a glutamatergic modulator that inhibits glutamate release and enhances AMPA
      trafficking and clearance of excessive synaptic glutamate resulting in neuroprotective
      properties. Riluzole is FDA-approved for the treatment of amyotrophic lateral sclerosis (ALS)
      and has been found to have antidepressant and anxiolytic properties in animals and in humans
      (Zarate et al., 2004). Posttraumatic stress disorder (PTSD) is a chronic and seriously
      debilitating anxiety disorder that develops following exposure to severe trauma, such as
      combat exposure. Structural magnetic resonance imaging has been used to measure the volume of
      crucial structures implicated in the pathophysiology of PTSD, with several morphometric
      studies confirming smaller hippocampal volume in PTSD patients. Current pharmacological
      treatment for PTSD, and particularly combat-related PTSD, is suboptimal. Drugs that alter
      neuronal survival pathways through reduction of glutamate activity may play a role in
      reversing the loss of neuronal integrity and possible focal atrophy in regions of the brain
      implicated in the pathophysiology of PTSD, potentially improving the symptoms of PTSD, as
      well as TBI. This study will evaluate the efficacy of acute riluzole treatment in active duty
      and Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), and Operation New Dawn
      (OND) veterans with PTSD, with or without mild TBI (mTBI), who are sub-optimally responsive
      to other medication treatments. A total of 158 active duty and OIF, OEF and OND veterans,
      aged 18 to 65 will be enrolled from WRNMMC and the Syracuse VA Medical Center to participate
      in this 8-week randomized, double- blind, placebo-controlled, parallel study. Patients who
      are suboptimal responders to their current psychotropic drugs will continue these at stable
      dosage for at least 2 weeks prior to randomization during the screening period. We
      hypothesize that those subjects with PTSD, with or without mTBI, who are only partially
      responsive to initial therapy and are subsequently randomized to augmentation therapy with
      Riluzole (100-200mg/day) will have a superior response rate compared to those subjects
      randomized to placebo.
    

Intervention name(s): Riluzole; Placebo (for Riluzole)
Intervention type(s): Drug; Drug
Other intervention name(s): Rilutek; Inert tablet manufactured to be indistinguishable from a Riluzole 50 mg tablet
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; TBI; Riluzole; Rilutek; augmentation; supplement; double blinded; clinical trial; placebo; RCT; Randomized Control Trial