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A mGlu2/3 Agonist in the Treatment of PTSD

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ClinicalTrials.gov Identifier: NCT02234687
Recruitment Status : Terminated (Principal investigator no longer at NYU. No data was analyzed.)
First Posted : September 9, 2014
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Drug: Pomaglumetad Methionil 160mg Drug: Pomaglumetad Methionil 40mg Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A mGlu2/3 Agonist in the Treatment of PTSD
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo, one dose
Drug: Placebo
Placebo, one dose, one time

Experimental: Pomaglumetad Methionil 160mg
Pomaglumetad Methionil 160mg, one dose, one time
Drug: Pomaglumetad Methionil 160mg
Pomaglumetad Methionil 160mg, one dose, one time
Other Name: LY2140023

Experimental: Pomaglumetad Methionil 40mg
Pomaglumetad Methionil 40mg, one dose, one time
Drug: Pomaglumetad Methionil 40mg
Pomaglumetad Methionil 40mg, one dose, one time
Other Name: LY2140023




Primary Outcome Measures :
  1. To evaluate the effect of 160mg and 40mg of pomaglumetad methionil [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234687


Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Charles Marmar, MD NYU School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02234687     History of Changes
Other Study ID Numbers: 13-00609
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: April 2016

Keywords provided by New York University School of Medicine:
post-traumatic stress disorder

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders