Back to resultsA mGlu2/3 Agonist in the Treatment of PTSD
Primary Purpose
Post-traumatic Stress Disorder
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Pomaglumetad Methionil 160mg
Pomaglumetad Methionil 40mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring post-traumatic stress disorder
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Pomaglumetad Methionil 40mg
Pomaglumetad Methionil 160mg
Arm Description
Placebo, one dose
Pomaglumetad Methionil 40mg, one dose, one time
Pomaglumetad Methionil 160mg, one dose, one time
Outcomes
Primary Outcome Measures
To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02234687
Brief Title
A mGlu2/3 Agonist in the Treatment of PTSD
Official Title
A mGlu2/3 Agonist in the Treatment of PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
Study Start Date
September 2014 (Actual)
Primary Completion Date
February 11, 2016 (Actual)
Study Completion Date
September 11, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
post-traumatic stress disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, one dose
Arm Title
Pomaglumetad Methionil 40mg
Arm Type
Experimental
Arm Description
Pomaglumetad Methionil 40mg, one dose, one time
Arm Title
Pomaglumetad Methionil 160mg
Arm Type
Experimental
Arm Description
Pomaglumetad Methionil 160mg, one dose, one time
Intervention Type
Drug
Intervention Name(s)
Pomaglumetad Methionil 160mg
Other Intervention Name(s)
LY2140023
Intervention Description
Pomaglumetad Methionil 160mg, one dose, one time
Intervention Type
Drug
Intervention Name(s)
Pomaglumetad Methionil 40mg
Other Intervention Name(s)
LY2140023
Intervention Description
Pomaglumetad Methionil 40mg, one dose, one time
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, one dose, one time
Primary Outcome Measure Information:
Title
To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Marmar, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A mGlu2/3 Agonist in the Treatment of PTSD
We'll reach out to this number within 24 hrs