a mglu2/3 agonist in the treatment of ptsd

Conditions: 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

Keywords: post-traumatic stress disorder