A mGlu2/3 Agonist in the Treatment of PTSD

Phase 1

Terminated

• Conditions: Post-traumatic Stress Disorder
• Interventions: Drug: Placebo; Drug: Pomaglumetad Methionil 40mg; Drug: Pomaglumetad Methionil 160mg

• Registration Number: NCT02234687
• Lead Sponsor: NYU Langone Health

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-09
• Primary Completion: 2016-02-11
• Results First Submitted: 2016-05-04
• Study Completion: 2016-09-11
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-08
• Last Update Submitted: 2018-03-08
• Results First Posted: 2018-11-02
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, one dose
Pomaglumetad Methionil 40mg	Pomaglumetad Methionil 40mg	Pomaglumetad Methionil 40mg, one dose, one time
Pomaglumetad Methionil 160mg	Pomaglumetad Methionil 160mg	Pomaglumetad Methionil 160mg, one dose, one time

Primary Outcome Measures

Name	Time	Method
To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil	6 months	To evaluate the effect of 160mg and 40mg challenge of the mGlu2/3 receptor agonist pomaglumetad methionil relative to placebo in mitigating fear-potentiated startle using the neutral-predictable-unpredictable fear-potentiated startle paradigm in adults with post-traumatic stress disorder (PTSD). The primary index of unpredictable fear will be the difference score between startle magnitude in safe and unpredictable conditions in the absence of the cue.