Back to resultsSafety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo oral capsule
NYX-783
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder
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.
Sites / Locations
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
- Aptinyx Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
NYX-783 Low Dose (10 mg QD)
NYX-783 High Dose (50 mg QD)
Arm Description
Outcomes
Primary Outcome Measures
CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores
CAPS-5 [Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] is a structured interview for diagnosis and assessment of PTSD. The assessor combines information about frequency and intensity of an item into a severity rating (0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: intrusions (items 1-5, minimum score 0, maximum score 20), avoidance (items 6-7, minimum score 0, maximum score 8), negative alterations in cognitions and mood (items 8-14, minimum score 0, maximum score 28), and alterations in arousal and reactivity (items 15-20, minimum score 0, maximum score 24). CAPS-5 Total Scores range from 0 to 80. A higher score corresponds to more severe PTSD.
Secondary Outcome Measures
PCL-5 (PTSD-Checklist for DSM-5)
Assess the effect of NYX-783 compared to placebo in changes of symptoms as measured by PCL-5. The PCL-5 ranges from 0 to 80; a higher score corresponds to more severe PTSD.
PSQI (Pittsburgh Sleep Quality Index) Global Score
Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI Global Score. The PSQI is a questionnaire to assess sleep quality and disturbances. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score >5 indicates significant sleep disturbance.
PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score
Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI-A Global Score. The PSQI-A score ranges from 0-21; lower scores represent less disruptive behavior.
BAC (Brief Assessment of Cognition) Symbol Coding
Assess the effect of NYX-783 compared to placebo in changes in cognitive function as measured by the BAC Symbol Coding. BAC symbol coding score is a count which ranges from 0 to 110; higher scores represent higher function.
CGI-S (Clinical Global Impression - Severity)
Assess the effect of NYX-783 compared to placebo in the change in global clinical severity of PTSD symptoms as measured by the CGI-S. The Clinical Global Impressions-Severity (CGI-S) score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects).
HADS-A (Hospital Anxiety and Depression Scale)
The HADS is a self-assessment tool consisting of two subscales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a Depression score (HADS-D), or can be added to produce a total score (HADS-T). Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-42 and sub scores for anxiety or depression ranging from 0-21 for each subscale. Higher scores represent more severe anxiety or depression. HADS-A is presented here.
Full Information
NCT ID
NCT04044664
First Posted
July 9, 2019
Last Updated
May 16, 2022
Sponsor
Aptinyx
Collaborators
Premier Research Group plc, Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04044664
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptinyx
Collaborators
Premier Research Group plc, Massachusetts General Hospital
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to receive placebo or NYX-783.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
NYX-783 Low Dose (10 mg QD)
Arm Type
Experimental
Arm Title
NYX-783 High Dose (50 mg QD)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Matching placebo capsules.
Intervention Type
Drug
Intervention Name(s)
NYX-783
Intervention Description
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Primary Outcome Measure Information:
Title
CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores
Description
CAPS-5 [Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] is a structured interview for diagnosis and assessment of PTSD. The assessor combines information about frequency and intensity of an item into a severity rating (0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: intrusions (items 1-5, minimum score 0, maximum score 20), avoidance (items 6-7, minimum score 0, maximum score 8), negative alterations in cognitions and mood (items 8-14, minimum score 0, maximum score 28), and alterations in arousal and reactivity (items 15-20, minimum score 0, maximum score 24). CAPS-5 Total Scores range from 0 to 80. A higher score corresponds to more severe PTSD.
Time Frame
Change from baseline to week 4 (Stage 1)
Secondary Outcome Measure Information:
Title
PCL-5 (PTSD-Checklist for DSM-5)
Description
Assess the effect of NYX-783 compared to placebo in changes of symptoms as measured by PCL-5. The PCL-5 ranges from 0 to 80; a higher score corresponds to more severe PTSD.
Time Frame
Change from baseline to week 4 (Stage 1)
Title
PSQI (Pittsburgh Sleep Quality Index) Global Score
Description
Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI Global Score. The PSQI is a questionnaire to assess sleep quality and disturbances. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score >5 indicates significant sleep disturbance.
Time Frame
Change from baseline to week 4 (Stage 1)
Title
PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score
Description
Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI-A Global Score. The PSQI-A score ranges from 0-21; lower scores represent less disruptive behavior.
Time Frame
Change from baseline to week 4 (Stage 1)
Title
BAC (Brief Assessment of Cognition) Symbol Coding
Description
Assess the effect of NYX-783 compared to placebo in changes in cognitive function as measured by the BAC Symbol Coding. BAC symbol coding score is a count which ranges from 0 to 110; higher scores represent higher function.
Time Frame
Change from baseline to week 4 (Stage 1)
Title
CGI-S (Clinical Global Impression - Severity)
Description
Assess the effect of NYX-783 compared to placebo in the change in global clinical severity of PTSD symptoms as measured by the CGI-S. The Clinical Global Impressions-Severity (CGI-S) score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects).
Time Frame
Change from baseline to week 4 (Stage 1)
Title
HADS-A (Hospital Anxiety and Depression Scale)
Description
The HADS is a self-assessment tool consisting of two subscales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a Depression score (HADS-D), or can be added to produce a total score (HADS-T). Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-42 and sub scores for anxiety or depression ranging from 0-21 for each subscale. Higher scores represent more severe anxiety or depression. HADS-A is presented here.
Time Frame
From baseline to week 4 (Stage 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Aptinyx Clinical Site
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
Facility Name
Aptinyx Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Aptinyx Clinical Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
30322
Country
United States
Facility Name
Aptinyx Clinical Site
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Aptinyx Clinical Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Aptinyx Clinical Site
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Aptinyx Clinical Site
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Aptinyx Clinical Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Aptinyx Clinical Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Aptinyx Clinical Site
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Aptinyx Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Aptinyx Clinical Site
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Aptinyx Clinical Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Aptinyx Clinical Site
City
Temecula
State/Province
California
ZIP/Postal Code
32591
Country
United States
Facility Name
Aptinyx Clinical Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Aptinyx Clinical Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Aptinyx Clinical Site
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Aptinyx Clinical Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Aptinyx Clinical Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Aptinyx Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Aptinyx
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Aptinyx Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Aptinyx Clinical Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60619
Country
United States
Facility Name
Aptinyx Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Aptinyx Clinical Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Aptinyx Clinical Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Aptinyx Clinical Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Aptinyx Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Aptinyx Clinical Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Aptinyx Clinical Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Aptinyx Clinical Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Aptinyx Clinical Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Aptinyx Clinical Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73107
Country
United States
Facility Name
Aptinyx Clinical Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Aptinyx Clinical Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Aptinyx Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Aptinyx Clinical Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
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