A mGlu2/3 Agonist in the Treatment of PTSD

NCT ID: NCT02234687

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-09-11

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).

Conditions

Post-traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo, one dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, one dose, one time

Pomaglumetad Methionil 40mg

Pomaglumetad Methionil 40mg, one dose, one time

Group Type: EXPERIMENTAL

Pomaglumetad Methionil 40mg

Intervention Type: DRUG

Pomaglumetad Methionil 40mg, one dose, one time

Pomaglumetad Methionil 160mg

Pomaglumetad Methionil 160mg, one dose, one time

Group Type: EXPERIMENTAL

Pomaglumetad Methionil 160mg

Intervention Type: DRUG

Pomaglumetad Methionil 160mg, one dose, one time

Interventions

Pomaglumetad Methionil 160mg

Pomaglumetad Methionil 160mg, one dose, one time

Intervention Type: DRUG

Pomaglumetad Methionil 40mg

Pomaglumetad Methionil 40mg, one dose, one time

Intervention Type: DRUG

Placebo

Placebo, one dose, one time

Intervention Type: DRUG

Other Intervention Names

LY2140023; LY2140023

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Marmar, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Other Identifiers

13-00609

Identifier Type: -

Identifier Source: org_study_id