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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
193
Unnamed facility
Oceanside, California, United States
Unnamed facility
Rancho Mirage, California, United States
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).
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Unnamed facility
Redlands, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Lauderhill, Florida, United States
Unnamed facility
North Miami, Florida, United States
Unnamed facility
Oakland Park, Florida, United States
Unnamed facility
Orlando, Florida, United States
...and 15 more locations
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