Clinical trial NCT02933606: Phase II Study of BNC210 in PTSD
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Study of BNC210 in Adults With Post-Traumatic Stress Disorder (PTSD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Bionomics Limited
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

* Signed and dated informed consent.
* Male or female between 18 and 70 years of age, inclusive.
* Diagnosed with current PTSD as defined by the CAPS-5 for DSM-5.
* Currently not using any psychiatric medications except for:

  * No more than one selective serotonin reuptake inhibitor (SSRI) (fluvoxamine is excluded) or serotonin noradrenaline reuptake inhibitor (SNRI) within the licensed prescribing dose range. Subjects must have been on a stable dose for at least 3 months prior and through Screening, with the intent to remain on the same dose through to Week 16.
  * As needed (PRN) use of benzodiazepines (BZD) at a frequency not exceeding 2 days per week in the 3 months prior to Screening. The total dose must not exceed 30 mg/day in diazepam equivalents.
* Subjects not currently receiving psychotherapy except long term supportive counseling or subjects that have received intensive regular psychotherapy for a minimum of three months prior to Screening.
* Females of childbearing potential must have a negative serum pregnancy. Females not of childbearing potential must be postmenopausal. Sterilized male patients must be at least 1 year post-vasectomy to be considered of non-child bearing potential. Females and males of childbearing potential must agree to use two effective methods of contraception.

Key Exclusion Criteria

* Current and ongoing exposure to the trauma that caused the PTSD.
* Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD. Each trial must have lasted at least 6 weeks to be considered a failed attempt. A trial that was terminated due to intolerability or side effects does not constitute a failed attempt.
* The use of psychiatric medications within 2 weeks of Screening except for SSRIs, SNRIs or limited PRN BZD use as per inclusion criterion 4. Restricted psychiatric medications include (but are not limited to) antidepressants not allowed by inclusion criterion 4, antianxiety drugs (except limited BZD use per inclusion criterion 4), mood stabilizers, stimulants, antipsychotics, hypnotics and acetylcholinesterase inhibitors.
* History of significant traumatic brain injury.
* Depression as measured by Montgomery-Äsberg depression scale (MADRS) rating \> 23.
* Bipolar and psychotic disorders as identified at Screening using the MINI International Neuropsychiatry Interview (V7.0) (M.I.N.I).
* A score ≥ 7 on the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) at Screening.
* History of seizure disorders, uncontrolled sleep apnoea or severe neurologic disease.
* Increased risk of suicide, defined as:

  * Any previous suicide attempt disclosed by the participant at Screening using the Columbia Suicide Severity Rating Scale (C-SSRS).
  * Any suicidal ideation with intent (yes to item 4 and / or 5) or suicidal behavior in the past year, as captured at Screening using the C-SSRS.
  * A score \> 4 on item 10 of the MADRS at Screening.
* The use of alprazolam or flunitrazepam within 3 months of Screening.
* Any clinically significant abnormalities in laboratory test results, vitals signs, or ECG at Screening.
* Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) at Screening.
* Any moderate to severe substance use disorder (any type) in the 12 months prior to Screening as identified by the DSM-5 using the M.I.N.I (V7.0).
* Current Australian serving Defense personnel or any member of the US military currently serving on active duty.
* Participants involved with ongoing insurance or workplace claims that in the opinion of the Investigator are likely to have an impact on the mental health, presentation or capacity of the patient to engage in the study.

Primary outcomes:
measure: Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score
timeFrame: 12 weeks.
Secondary outcomes:
measure: Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).
timeFrame: 12 weeks.
measure: Montgomery- Åsberg Depression Rating Scale (MADRS).
timeFrame: 12 weeks.
measure: Hamilton Anxiety Rating Scale (HAM-A).
timeFrame: 12 weeks
measure: Clinical Global Impressions - Severity Scale (CGI-S).
timeFrame: 12 weeks
measure: Clinical Global Impressions - Improvement Scale (CGI-I).
timeFrame: 12 weeks
measure: Patient Global Impressions - Severity Scale (PGI-S).
timeFrame: 12 weeks.
measure: Patient Global Impression - Improvement Scale (PGI-I).
timeFrame: 12 weeks.
measure: Assessment of Quality of Life (AQoL-8D).
timeFrame: 12 weeks.
measure: Social Functioning: Sheehan Disability Scale (SDS).
timeFrame: 12 weeks.
measure: Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).
timeFrame: 12 weeks.
measure: CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Oceanside
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Redlands
country: United States
state: California
city: Riverside
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lauderhill
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Oakland Park
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Hoffman Estates
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: New Bedford
country: United States
state: Massachusetts
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Canton
country: United States
state: Ohio
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Penrith
country: Australia
state: New South Wales
city: Auchenflower
country: Australia
state: Queensland
city: Toowong
country: Australia
state: Queensland
city: Elizabeth Vale
country: Australia
state: South Australia
city: St Kilda
country: Australia
state: Victoria
Study officials:
References: