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Completed

NCT Number: NCT04951076

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

The purpose of this study is to assess the effects of BNC210 compared to placebo on Post-Traumatic Stress Disorder (PTSD) symptom severity as measured by the Clinician Administered PTSD scale for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ATTUNE Study Clinical Trial Site, Barnsley, United Kingdom

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About this study

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study with a 12 week, 2-arm treatment period. Participants will attend a Screening visit within 3 weeks before randomization to confirm eligibility. Approximately 200 participants will be randomized using a 1:1 ratio to receive either BNC210 900 mg twice daily (b.i.d.) or matched placebo. Participants will then complete 12 weeks of treatment with their allocated study intervention. Participants will return to their study site at 2-weekly intervals to complete study assessments. Participants are then requested to attend a Follow-up visit at Week 15 (i.e., 3 weeks after their last study intervention is administered).

Who can participate

Healthy volunteers accepted: No

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

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 Montgomery Asberg Depression Rating Scale (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

Treatment and study plan

BNC210

Drug

BNC210 900 mg twice daily (b.i.d.) for 12 weeks

Placebo

Drug

Placebo twice daily (b.i.d.) for 12 weeks

Primary outcomes

  1. Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks,12 weeks

    The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.

Secondary outcomes

  1. Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Criterion B (Intrusive Thoughts) is a 5-item sub section of the CAPS-5 scale that assesses intrusion symptoms associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 20, with higher scores indicating greater severity of intrusion symptoms.

  2. Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Criterion C (Avoidance) is a 2-item sub section of the CAPS-5 scale that assesses avoidance of stimuli associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 8, with higher scores indicating greater severity of avoidance symptoms.

  3. Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Criterion D (Negative Alterations in Cognitions and Mood) is a 7-item sub section of the CAPS-5 scale that assesses negative alterations in cognitions and mood associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 28, with higher scores indicating greater severity of negative alterations in cognitions and mood symptoms.

  4. Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Criterion E (Arousal and Reactivity) is a 6-item sub section of the CAPS-5 scale that assesses marked alterations in arousal and reactivity associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 24, with higher scores indicating greater severity of arousal and reactivity symptoms.

  5. Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    The MADRS is a 10-item clinician-rated questionnaire to measure the presence and severity of depressive episodes. Each item is rated on a scale of 0 to 6. The score from each item is combined into a total score ranging from 0 to 60, with higher scores indicating greater severity of depressive episodes.

  6. Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    The HAM-A is an interview questionnaire that measures severity of anxiety symptoms based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior during the interview. Each parameter is rated on a scale of 0 (not present) to 4 (very severe). The score from each parameter is combined into a total score. Scores range from 0 to 56, with higher scores indicating greater severity of anxiety symptoms.

  7. Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    The CGI-S is a rating scale designed to assess the overall severity of the participant's symptoms. Severity is rated on a scale from 1 (normal, not at all ill) to 7 (among the most extremely ill of participants), with a higher score indicating greater severity of symptoms.

  8. Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Change from Baseline on patient-reported global functioning

    The PGI-S is a patient self-reported counterpart of the CGI-S designed to assess the patient's impression of their perceived severity of overall symptoms.Severity is rated on the PGI-S from 1 (normal) to 6 (very severe), with a higher score indicating greater severity of symptoms.

  9. Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    The ISI is a brief self-report instrument measuring both nocturnal and diurnal symptoms of insomnia. The ISI comprises seven items, each scored from 0 to 4. The scores from each of the 7 questions are added up to get a total score of 0 to 28, with a higher score indicating a higher level of symptom severity.

  10. Change From Baseline on Sheehan Disability Scale (SDS) Scores After 12 Weeks

    Time frame: Baseline, 4 weeks, 8 weeks,12 weeks

    The SDS is a rating scale designed to measure impairment in three domains: work/school, social life, and family life/home responsibilities. Each item is rated on a scale of 0 (not at all) to 10 (extremely), for a total score of 0 to 30, with a higher score indicating a higher degree of impairment.

  11. Change From Baseline on PTSD Checklist for DSM-5 (PCL-5) Scores After 12 Weeks

    Time frame: Baseline, 12 weeks

    The PCL-5 is a 20-item self-report assessment of the 20 DSM-5 symptoms of PTSD. Each symptom is rated on a scale from 0 (not at all) to 4 (extremely). Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.

Sponsors and collaborators

Lead sponsor

Bionomics Limited

Industry

Registry information

Official study title

A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder (PTSD)

Acronym: ATTUNE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2021
Registry last updated
Feb 6, 2025

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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