Status:
TERMINATED
A mGlu2/3 Agonist in the Treatment of PTSD
Lead Sponsor:
NYU Langone Health
Conditions:
Post-traumatic Stress Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 mGlu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02234687
Start Date
September 1 2014
End Date
September 11 2016
Last Update
November 2 2018
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