Post-Traumatic Stress DisorderPhase 2NCT04044664
Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
A Phase 2 study testing NYX-783 in people with Post-Traumatic Stress Disorder, run by Aptinyx at 37 sites in United States.
Trial summary
To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- NYX-783
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 37 sitesUnited States
- Study dates
- 25 Jan 2019to 5 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Aptinyx
Atlanta, Georgia, 30329
Aptinyx Clinical Site
Atlanta, Georgia, 30331
Aptinyx Clinical Site
Austin, Texas, 78737
Aptinyx Clinical Site
Bellevue, Washington, 98007
Aptinyx Clinical Site
Bellflower, California, 90706
Aptinyx Clinical Site
Berlin, New Jersey, 08009
Aptinyx Clinical Site
Boston, Massachusetts, 02131
Aptinyx Clinical Site
Canton, Ohio, 44720
Aptinyx Clinical Site
Cedarhurst, New York, 11516
Aptinyx Clinical Site
Cincinnati, Ohio, 45219
Aptinyx Clinical Site
Colorado Springs, Colorado, 80910
Aptinyx Clinical Site
Glendale, California, 91206
Aptinyx Clinical Site
Hoffman Estates, Illinois, 60619
Aptinyx Clinical Site
Imperial, California, 92251
Aptinyx Clinical Site
Jacksonville, Florida, 32256
Aptinyx Clinical Site
Las Vegas, Nevada, 89102
Aptinyx Clinical Site
Lauderhill, Florida, 33319
Aptinyx Clinical Site
Little Rock, Arkansas, 30322
Aptinyx Clinical Site
Memphis, Tennessee, 38119
Aptinyx Clinical Site
New York, New York, 10036
Aptinyx Clinical Site
Norwich, Connecticut, 06360
Aptinyx Clinical Site
Oakland, California, 94607
Aptinyx Clinical Site
Oceanside, California, 92056
Aptinyx Clinical Site
Oklahoma City, Oklahoma, 73107
Aptinyx Clinical Site
Orange, California, 92868
Aptinyx Clinical Site
Orlando, Florida, 32801
Aptinyx Clinical Site
Phoenix, Arizona, 85012
Aptinyx Clinical Site
Riverside, California, 92503
Aptinyx Clinical Site
Salisbury, North Carolina, 28144
Aptinyx Clinical Site
San Antonio, Texas, 78229
Aptinyx Clinical Site
San Diego, California, 92103
Aptinyx Clinical Site
San Marcos, California, 92078
Aptinyx Clinical Site
Santa Ana, California, 92705
Aptinyx Clinical Site
Staten Island, New York, 10312
Aptinyx Clinical Site
Temecula, California, 32591
Aptinyx Clinical Site
Torrance, California, 90502
Aptinyx Clinical Site
Tuscaloosa, Alabama, 35404
About this study
Official title: A Study to Evaluate the 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.
Read the 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).
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Placebo oral capsule, NYX-783
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral capsuleDrug
Matching placebo capsules.
NYX-783Drug
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| NYX-783 Low Dose (10 mg QD) | Experimental | Not described Receives: Drug: NYX-783 |
| NYX-783 High Dose (50 mg QD) | Experimental | Not described Receives: Drug: NYX-783 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to week 4 (Stage 1)
Secondary outcomes (6)
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.
Measured: Change from baseline to week 4 (Stage 1)
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.
Measured: Change from baseline to week 4 (Stage 1)
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.
Measured: Change from baseline to week 4 (Stage 1)
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.
Measured: Change from baseline to week 4 (Stage 1)
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).
Measured: Change from baseline to week 4 (Stage 1)
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.
Measured: From baseline to week 4 (Stage 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start25 Jan 2019
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to receive placebo or NYX-783.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptinyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044664
- Sponsor's protocol ID
- NYX-783-2004
- Status last verified
- May 2022
- First submitted
- 9 Jul 2019
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04044664
- Acronym / sponsor ID
- NYX-783-2004
- Conditions
- Post-Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- AptinyxIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research, Massachusetts General Hospital
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Posted 13 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomized to receive placebo or NYX-783.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsule |
| NYX-783 Low Dose (10 mg QD) | Experimental | Drug: NYX-783 |
| NYX-783 High Dose (50 mg QD) | Experimental | Drug: NYX-783 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo oral capsuleMatching placebo capsules. | Drug | Placebo |
| NYX-783NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). | Drug | NYX-783 High Dose (50 mg QD), NYX-783 Low Dose (10 mg QD) |
Primary outcome
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.
6 secondary outcomes
PCL-5 (PTSD-Checklist for DSM-5)
Time frame: Change from baseline to week 4 (Stage 1)
PSQI (Pittsburgh Sleep Quality Index) Global Score
Time frame: Change from baseline to week 4 (Stage 1)
PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score
Time frame: Change from baseline to week 4 (Stage 1)
BAC (Brief Assessment of Cognition) Symbol Coding
Time frame: Change from baseline to week 4 (Stage 1)
CGI-S (Clinical Global Impression - Severity)
Time frame: Change from baseline to week 4 (Stage 1)
HADS-A (Hospital Anxiety and Depression Scale)
Time frame: From baseline to week 4 (Stage 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NYX-783 in people with Post-Traumatic Stress Disorder, run by Aptinyx at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.