A mGlu2/3 Agonist in the Treatment of PTSD
| Status: | Terminated |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/13/2017 |
| Start Date: | September 2014 |
| End Date: | February 2016 |
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).
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).
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
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