A mGlu2/3 Agonist in the Treatment of PTSD

NYU Langone Health

Status and phase: Terminated; Phase 1

Conditions: Post-traumatic Stress Disorder

Treatments: Drug: Placebo; Drug: Pomaglumetad Methionil 40mg; Drug: Pomaglumetad Methionil 160mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02234687

13-00609

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo, one dose

Treatment:

Drug: Placebo

Pomaglumetad Methionil 40mg

Experimental group

Description:

Pomaglumetad Methionil 40mg, one dose, one time

Treatment:

Drug: Pomaglumetad Methionil 40mg

Pomaglumetad Methionil 160mg

Experimental group

Description:

Pomaglumetad Methionil 160mg, one dose, one time

Treatment:

Drug: Pomaglumetad Methionil 160mg