A mGlu2/3 Agonist in the Treatment of PTSD
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Pomaglumetad Methionil 160mg; Pomaglumetad Methionil 40mg; Placebo
Intervention description: Pomaglumetad Methionil 160mg, one dose, one time; Pomaglumetad Methionil 40mg, one dose, one time; Placebo, one dose, one time
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: post-traumatic stress disorder

Summary:

      In this study, we propose to employ a randomized, double-blind, placebo-controlled,
      outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40
      mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating
      fear-potentiated startle response and behavior in adults with post-traumatic stress disorder
      (PTSD) (N=30). Each participant will receive a single dose of the study drug (40 mg vs 160 mg
      vs placebo in a 1:1:1 ratio).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women between 18 and 60 years of age, any race

          -  Primary, current Axis I diagnosis of post traumatic stress disorder (PTSD) according
             to Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria

          -  Able to provide written informed consent

        Exclusion Criteria:

          -  Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic
             disorder including schizophrenia, schizoaffective disorder, bipolar disorder

          -  History of moderate or severe traumatic brain injury (TBI) with loss of consciousness

          -  Lifetime history of seizure disorder

          -  Current diagnosis of obsessive-compulsive disorder (OCD)

          -  Current diagnosis of bulimia nervosa or anorexia nervosa; or substance use disorder

          -  Alcohol or drug abuse in the past 90 days, or dependence in the past year.

          -  Individuals with a cumulative lifetime history of intravenous substance abuse longer
             than 1 year.

          -  Severe dissociation, defined as a Clinician Administered Dissociative States Scale
             (CADSS) score greater than 60 at baseline

          -  Patients with creatinine clearance <60 milliliters (mL)/min (moderate renal
             impairment)

          -  Current pregnancy or breast feeding; medical conditions that could interfere with
             correct interpretation of study data, i.e., individuals with the following medical
             conditions will be excluded: cancer in the past year, stroke, heart attack, angina,
             neurological disease (multiple sclerosis, epilepsy, Parkinson's disease), central
             nervous system (CNS) lesions including TBI with loss of consciousness, dementing
             illness, and/or liver or kidney disease. Patients with QT interval >450 msec (males)
             and >470 msec (females).

          -  Participants who have started new medication regimen for PTSD within 3 months prior to
             study start and subjects taking fluoxetine

          -  Current suicidality defined by emergent Columbia Suicide Severity Rating Scale
             (CSSRS)-defined suicidal behavior, a suicidal ideation score of 5 (indicating active
             suicidal ideation with specific plan and some level of intent) or 4 (indicating active
             suicidal ideation with some intent to act, without specific plan) on the CSSRS or in
             the absence of a CSSRS suicidal ideation score of 5 or 4 or CSSRS-defined suicidal
             behavior, if the investigator determines the patient to have a significant short-term
             risk for a suicide attempt.

          -  Individuals with active suicidal risk, active self-mutilation or aggressive behavior
             with threatening behavior toward others within the past year, as judged by the
             Principal Investigator

          -  Pregnant or lactating women

          -  Legal and Financial: Current legal proceedings resulting from the traumatic events.
             People whose continued receipt of financial benefits is contingent upon maintaining
             PTSD symptoms or who are waiting for a decision concerning the receipt of financial
             benefits based upon PTSD symptoms