Clinical trial NCT04044664: Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Official title: A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Aptinyx
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
name: Massachusetts General Hospital
First posted: 2019-08-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to receive placebo or NYX-783.
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population.

Detailed description: The study will be a 10 to 12-week study, including a 1 to 3-week screening Period, followed by a double-blind, randomized, placebo-controlled, parallel-group Treatment Period, and a 1-week follow-up Period. Subjects eligible for the study will be randomized to receive either NYX-783 (4-weeks) or placebo (4 or 8-weeks).

Eligibility criteria: Inclusion Criteria:

* A primary diagnosis of PTSD \[Post Traumatic Stress Disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)\] with the primary traumatic event occurring ≥12 months prior to screening.
* PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.
* CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.

Exclusion Criteria:

* Complex PTSD.
* Trauma focused psychotherapies.
* Primary traumatic event occurred prior to 2001.
* Primary traumatic event was followed by further major traumatic life episodes.
* Other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma)
* Current use of medications with primarily central nervous system activities
* Other clinically significant medical histories that may interfere with completing the study.

Primary outcomes:
measure: CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores
timeFrame: Change from baseline to week 4 (Stage 1)
Secondary outcomes:
measure: PCL-5 (PTSD-Checklist for DSM-5)
timeFrame: Change from baseline to week 4 (Stage 1)
measure: PSQI (Pittsburgh Sleep Quality Index) Global Score
timeFrame: Change from baseline to week 4 (Stage 1)
measure: PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score
timeFrame: Change from baseline to week 4 (Stage 1)
measure: BAC (Brief Assessment of Cognition) Symbol Coding
timeFrame: Change from baseline to week 4 (Stage 1)
measure: CGI-S (Clinical Global Impression - Severity)
timeFrame: Change from baseline to week 4 (Stage 1)
measure: HADS-A (Hospital Anxiety and Depression Scale)
timeFrame: From baseline to week 4 (Stage 1)
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Aptinyx Clinical Site
state: Alabama
city: Phoenix
country: United States
facility: Aptinyx Clinical Site
state: Arizona
city: Little Rock
country: United States
facility: Aptinyx Clinical Site
state: Arkansas
city: Bellflower
country: United States
facility: Aptinyx Clinical Site
state: California
city: Glendale
country: United States
facility: Aptinyx Clinical Site
state: California
city: Imperial
country: United States
facility: Aptinyx Clinical Site
state: California
city: Oakland
country: United States
facility: Aptinyx Clinical Site
state: California
city: Oceanside
country: United States
facility: Aptinyx Clinical Site
state: California
city: Orange
country: United States
facility: Aptinyx Clinical Site
state: California
city: Riverside
country: United States
facility: Aptinyx Clinical Site
state: California
city: San Diego
country: United States
facility: Aptinyx Clinical Site
state: California
city: San Marcos
country: United States
facility: Aptinyx Clinical Site
state: California
city: Santa Ana
country: United States
facility: Aptinyx Clinical Site
state: California
city: Temecula
country: United States
facility: Aptinyx Clinical Site
state: California
city: Torrance
country: United States
facility: Aptinyx Clinical Site
state: California
city: Colorado Springs
country: United States
facility: Aptinyx Clinical Site
state: Colorado
city: Norwich
country: United States
facility: Aptinyx Clinical Site
state: Connecticut
city: Jacksonville
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Lauderhill
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Orlando
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Aptinyx
state: Georgia
city: Atlanta
country: United States
facility: Aptinyx Clinical Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Aptinyx Clinical Site
state: Illinois
city: Boston
country: United States
facility: Aptinyx Clinical Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Aptinyx Clinical Site
state: Nevada
city: Berlin
country: United States
facility: Aptinyx Clinical Site
state: New Jersey
city: Cedarhurst
country: United States
facility: Aptinyx Clinical Site
state: New York
city: New York
country: United States
facility: Aptinyx Clinical Site
state: New York
city: Staten Island
country: United States
facility: Aptinyx Clinical Site
state: New York
city: Salisbury
country: United States
facility: Aptinyx Clinical Site
state: North Carolina
city: Canton
country: United States
facility: Aptinyx Clinical Site
state: Ohio
city: Cincinnati
country: United States
facility: Aptinyx Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Aptinyx Clinical Site
state: Oklahoma
city: Memphis
country: United States
facility: Aptinyx Clinical Site
state: Tennessee
city: Austin
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Bellevue
country: United States
facility: Aptinyx Clinical Site
state: Washington
Study officials:
References: