A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD) (ATTUNE)

This is an interventional treatment trial for Post-Traumatic Stress Disorder Read More

Inclusion Criteria:

• Participants with a current diagnosis of PTSD as defined by the CAPS-5 for DSM-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at Screening and Baseline and no >25% decrease in Score from Screening to Baseline
• The index trauma event must have occurred in adulthood, i.e., when the participant was ≥18 years of age
• Suitable contraception use in line with protocol requirements
• Ability to swallow tablets

Exclusion Criteria:

• A period of less than 6 months since the index trauma event
• Current and ongoing exposure to the trauma that caused the PTSD
• Complex PTSD
• Severe depression as measured by a score of ≥ 35 on the MADRS
• Borderline personality disorder, bipolar disorder and other psychotic disorders
• Use of antidepressant medications within 30 days (fluoxetine within 90 days) of Screening. The use of alprazolam, flunitrazepam and chronic daily use of other benzodiazepines within 90 day of Screening.
• Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD.
• Concurrent trauma-based psychotherapy such as Cognitive Behavior Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy. Participants may however continue to receive supportive counseling that has been in place for a minimum of three months prior to Screening.
• Any moderate or severe substance use disorder in the past 12 months
• Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk