A Phase 2 interventional study of BNC210 and Placebo in Post-Traumatic Stress Disorder, sponsored by Bionomics Limited. Completed at 25 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-27.
Sponsored by Bionomics Limited · Phase 2, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled study, evaluating the effects of BNC210 versus placebo on the symptoms of Post-Traumatic Stress Disorder, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
The secondary objectives of the study are to evaluate the effects of BNC210 on anxiety, depression, global functioning and patient reported outcomes in patients with PTSD. Safety and tolerability of BNC210 will also be assessed. Study participants will receive 12 weeks of blinded treatment followed by a 3 week follow-up period.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 193 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Bionomics Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Currently not using any psychiatric medications except for:
Key Exclusion Criteria
Increased risk of suicide, defined as:
Suspension administered orally for 12 weeks.
Drug: BNC210
Suspension administered orally for 12 weeks.
Drug: BNC210
Suspension administered orally for 12 weeks.
Drug: BNC210
Suspension administered orally for 12 weeks.
Drug: Placebo
Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score
Investigator-rated PTSD symptom severity. The range for the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5)Total Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.
Time frame: 12 weeks.
Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).
Self-reported PTSD symptom severity. The range for the Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.
Time frame: 12 weeks.
Montgomery- Åsberg Depression Rating Scale (MADRS).
Depression severity. The range for the Montgomery- Åsberg Depression Rating Scale (MADRS) is 0-60, with a higher score meaning a higher severity of disease.
Time frame: 12 weeks.
Hamilton Anxiety Rating Scale (HAM-A).
Anxiety severity. The range for the Hamilton Anxiety Rating Scale (HAM-A) is 0-56, with a higher score meaning a higher severity of disease.
Time frame: 12 weeks
Clinical Global Impressions - Severity Scale (CGI-S).
Clinician's assessment of global symptom severity using the Clinical Global Impressions - Severity Scale (CGI-S).
Time frame: 12 weeks
Clinical Global Impressions - Improvement Scale (CGI-I).
Clinician's assessment of global symptom improvement using the Clinical Global Impressions - Improvement Scale (CGI-I).
Time frame: 12 weeks
Patient Global Impressions - Severity Scale (PGI-S).
Self-reported global symptom severity using the Patient Global Impressions - Severity Scale (CGI-S).
Time frame: 12 weeks.
Patient Global Impression - Improvement Scale (PGI-I).
Self-reported global symptom improvement using the Patient Global Impression - Improvement Scale (PGI-I).
Time frame: 12 weeks.
Assessment of Quality of Life (AQoL-8D).
Quality of Life. The range for the Assessment of Quality of Life (AQoL-8D) score is 35-176, with a higher score meaning a lower quality of life.
Time frame: 12 weeks.
Social Functioning: Sheehan Disability Scale (SDS).
Social functioning. The range for the Total Score on the Sheehan Disability Scale (SDS) is 0-30, with a higher score meaning a higher degree of impairment.
Time frame: 12 weeks.
Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).
Sleep quality and duration. The range for the Pittsburgh Sleep Quality Index (PSQI) score is 0-21, with a higher score meaning a worse level of sleep quality
Time frame: 12 weeks.
CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment
The CANTAB global composite score is based on the Z scores for CANTAB outcome measures (PAL first attempt memory score (PALFAMS), PAL total errors adjusted (PALTEA), SWM between errors (SWMBE), SWM strategy (SWMS), RVP A' prime (RVPA), RVP median latency (RVPMDL). Specifically, the global composite score of cognitive function is as follows: CANTAB global composite score of cognitive function = (ZPALFAMS + ZPALTEA + ZSWMBE + ZSWMS + ZRVPA + ZRVPMDL) /8 (higher is better) A Z-score of 0 represents the population mean. A Z-score above 0 indicates cognition higher than the population mean and Z-score below 0 indicates cognition lower than the population mean
Time frame: 12 Weeks
| Milestone | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Started | 49 | 48 | 47 | 49 |
| Completed | 33 | 39 | 33 | 30 |
| Not completed | 16 | 9 | 14 | 19 |
Investigator-rated PTSD symptom severity. The range for the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5)Total Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.
| score on a scale | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score | 15.26 (11.2 to 19.3) | 16.62 (12.3 to 20.9) | 19.76 (15.5 to 24.0) | 14.57 (9.8 to 19.4) |
Self-reported PTSD symptom severity. The range for the Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.
| score on a scale | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5). | 25.02 (19.1 to 31.0) | 20.99 (15.3 to 26.7) | 29.97 (23.5 to 36.4) | 24.65 (17.8 to 31.5) |
Depression severity. The range for the Montgomery- Åsberg Depression Rating Scale (MADRS) is 0-60, with a higher score meaning a higher severity of disease.
| score on a scale | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Montgomery- Åsberg Depression Rating Scale (MADRS). | 9.48 (6.7 to 12.3) | 10.25 (7.7 to 12.8) | 12.16 (9.4 to 14.9) | 8.94 (6.1 to 11.8) |
Anxiety severity. The range for the Hamilton Anxiety Rating Scale (HAM-A) is 0-56, with a higher score meaning a higher severity of disease.
| score on a scale | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Hamilton Anxiety Rating Scale (HAM-A). | 9.03 (6.6 to 11.5) | 9.94 (7.6 to 12.3) | 10.55 (8.1 to 13.0) | 7.94 (5.3 to 10.6) |
Clinician's assessment of global symptom severity using the Clinical Global Impressions - Severity Scale (CGI-S).
| Participants | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Normal, not at all ill | 10 | 5 | 5 | 10 |
| Borderline mentally ill | 5 | 3 | 6 | 6 |
| Mildly ill | 8 | 16 | 8 | 5 |
| Moderately ill | 9 | 13 | 9 | 7 |
| Markedly ill | 1 | 2 | 3 | 1 |
| Severely ill | 0 | 0 | 2 | 1 |
| Among the most extremely ill patients | 0 | 0 | 0 | 0 |
Clinician's assessment of global symptom improvement using the Clinical Global Impressions - Improvement Scale (CGI-I).
| Participants | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Very Much Improved/Much Improved | 22 | 23 | 15 | 19 |
| Other | 11 | 16 | 18 | 11 |
Self-reported global symptom severity using the Patient Global Impressions - Severity Scale (CGI-S).
| Participants | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Normal | 11 | 6 | 6 | 10 |
| Mild | 8 | 21 | 14 | 13 |
| Moderate | 12 | 11 | 9 | 3 |
| Severe | 2 | 1 | 4 | 4 |
Self-reported global symptom improvement using the Patient Global Impression - Improvement Scale (PGI-I).
| Participants | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Very Much/Much Improved | 17 | 20 | 18 | 20 |
| Other | 16 | 19 | 15 | 10 |
Quality of Life. The range for the Assessment of Quality of Life (AQoL-8D) score is 35-176, with a higher score meaning a lower quality of life.
| score on a scale | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Assessment of Quality of Life (AQoL-8D). | 77.95 (71.4 to 84.5) | 76.79 (70.3 to 83.3) | 85.47 (78.0 to 93.0) | 81.05 (73.3 to 88.9) |
Social functioning. The range for the Total Score on the Sheehan Disability Scale (SDS) is 0-30, with a higher score meaning a higher degree of impairment.
| score on a scale | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Social Functioning: Sheehan Disability Scale (SDS). | 8.84 (6.2 to 11.5) | 6.66 (4.0 to 9.3) | 10.32 (7.5 to 13.1) | 8.47 (5.3 to 11.7) |
Sleep quality and duration. The range for the Pittsburgh Sleep Quality Index (PSQI) score is 0-21, with a higher score meaning a worse level of sleep quality
| score on a scale | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI). | 8.80 (7.5 to 10.1) | 8.83 (7.6 to 10.1) | 9.15 (7.7 to 10.6) | 8.00 (6.4 to 9.6) |
The CANTAB global composite score is based on the Z scores for CANTAB outcome measures (PAL first attempt memory score (PALFAMS), PAL total errors adjusted (PALTEA), SWM between errors (SWMBE), SWM strategy (SWMS), RVP A' prime (RVPA), RVP median latency (RVPMDL). Specifically, the global composite score of cognitive function is as follows: CANTAB global composite score of cognitive function = (ZPALFAMS + ZPALTEA + ZSWMBE + ZSWMS + ZRVPA + ZRVPMDL) /8 (higher is better) A Z-score of 0 represents the population mean. A Z-score above 0 indicates cognition higher than the population mean and Z-score below 0 indicates cognition lower than the population mean
| Composite Z score | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment | 0.06 (-0.1 to 0.2) | 0.12 (0.0 to 0.2) | 0.18 (0.1 to 0.3) | 0.02 (-0.1 to 0.2) |
Collected over 15 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BNC210 600 mg b.i.d. | 0/48 (0%) | 0/48 (0%) | 31/48 (64.6%) |
| BNC210 300 mg b.i.d. | 0/48 (0%) | 1/48 (2.1%) | 42/48 (87.5%) |
| BNC210 150 mg b.i.d. | 0/47 (0%) | 0/47 (0%) | 30/47 (63.8%) |
| Placebo b.i.d. | 0/49 (0%) | 1/49 (2%) | 45/49 (91.8%) |
| Event | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| Elevated Liver Function TestsInvestigations | 0/48 | 1/48 | 0/47 | 0/49 |
| Acute AbdomenGastrointestinal disorders | 0/48 | 0/48 | 0/47 | 1/49 |
| Event | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. |
|---|---|---|---|---|
| HeadacheNervous system disorders | 3/48 | 10/48 | 4/47 | 12/49 |
| Upper Respiratory Tract InfectionInfections and infestations | 4/48 | 3/48 | 6/47 | 2/49 |
| DiarrhoeaGastrointestinal disorders | 4/48 | 6/48 | 4/47 | 6/49 |
| NauseaGastrointestinal disorders | 4/48 | 4/48 | 2/47 | 6/49 |
| FatigueGeneral disorders | 2/48 | 5/48 | 2/47 | 1/49 |
| NasopharyngitisInfections and infestations | 4/48 | 2/48 | 1/47 | 1/49 |
| DizzinessNervous system disorders | 2/48 | 3/48 | 1/47 | 4/49 |
| Dry MouthGastrointestinal disorders | 3/48 | 0/48 | 3/47 | 3/49 |
| SomnolenceNervous system disorders | 3/48 | 3/48 | 2/47 | 1/49 |
| Viral InfectionInfections and infestations | 1/48 | 3/48 | 2/47 | 0/49 |
| Age, Categorical(Participants) | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. | Total |
|---|---|---|---|---|---|
| <=18 years | 1 | 0 | 1 | 0 | 2 |
| Between 18 and 65 years | 46 | 48 | 46 | 49 | 189 |
| >=65 years | 1 | 0 | 0 | 0 | 1 |
| Sex: Female, Male(Participants) | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. | Total |
|---|---|---|---|---|---|
| Female | 25 | 26 | 31 | 30 | 112 |
| Male | 23 | 22 | 16 | 19 | 80 |
| Race (NIH/OMB)(Participants) | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 | 2 |
| Black or African American | 16 | 11 | 8 | 10 | 45 |
| White | 30 | 35 | 36 | 34 | 135 |
| More than one race | 1 | 1 | 2 | 3 | 7 |
| Unknown or Not Reported | 1 | 1 | 0 | 1 | 3 |
| Region of Enrollment(participants) | BNC210 600 mg b.i.d. | BNC210 300 mg b.i.d. | BNC210 150 mg b.i.d. | Placebo b.i.d. | Total |
|---|---|---|---|---|---|
| United States | 41 | 41 | 41 | 38 | 161 |
| Australia | 7 | 7 | 6 | 11 | 31 |
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