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Completed

NCT Number: NCT04044664

Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder

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

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aptinyx Clinical Site, Tuscaloosa, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo oral capsule

Drug

Matching placebo capsules.

NYX-783

Drug

NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Primary outcomes

  1. CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores

    Time frame: Change from baseline to week 4 (Stage 1)

    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 outcomes

  1. PCL-5 (PTSD-Checklist for DSM-5)

    Time frame: Change from baseline to week 4 (Stage 1)

    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.

  2. PSQI (Pittsburgh Sleep Quality Index) Global Score

    Time frame: Change from baseline to week 4 (Stage 1)

    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.

  3. PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score

    Time frame: Change from baseline to week 4 (Stage 1)

    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.

  4. BAC (Brief Assessment of Cognition) Symbol Coding

    Time frame: Change from baseline to week 4 (Stage 1)

    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.

  5. CGI-S (Clinical Global Impression - Severity)

    Time frame: Change from baseline to week 4 (Stage 1)

    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).

  6. HADS-A (Hospital Anxiety and Depression Scale)

    Time frame: From baseline to week 4 (Stage 1)

    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.

Sponsors and collaborators

Lead sponsor

Aptinyx

Industry

Collaborators

  • Massachusetts General Hospital
  • Premier Research

Registry information

Official study title

A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2019
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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