Mental and Behavioural Disorders
Conditions
Interventions
Placebo
Sponsors
Tonix Pharmaceuticals Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 75 years of age at the time signing informed consent from (ICF), inclusive. 2. Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for Diagnostic and Statistical Manual of Mental Disorders-Version 5 (DSM-5) and of sufficient symptom severity, defined as all of the following at Screening Visit 1 using the Diagnostic version (1-month recall): a. The A criterion is 1=YES, and b. At least ONE item of the B criterion items must have a score of =2, and c. At least ONE item of the C criterion items must have a score of =2, and d. At least TWO items of the D criterion items must have a score of =2, and e. At least TWO items of the E criterion items must have a score of =2, and f. The F item 22 criterion is 1=YES (=1-month duration of symptoms) g. At least ONE item of the G items must have a score of =2, and h. The total CAPS-5 score (of items 1 through 20 is) =29 3. Index trauma(s) resulting in PTSD must meet the following: a. DSM-5 criterion A for PTSD as described in the CAPS-5 and Criterion A – Assessment Form (CA-AF), and b. Must have occurred within 9 years of Screening Visit 1, and c. Must have occurred when the patient was =18 years of age. 4. Willing and able to withdraw and refrain from opioids for the course of the study. 5. Willing to refrain from use of all other formulations of cyclobenzaprine for the course of the study. 6. Willing and able to refrain from antidepressants, antipsychotics, mood stabilizers, anticonvulsants, benzodiazepines, non-benzodiazepine hypnotics, buspirone, stimulants (e.g. amphetamines, methylphenidate, modafinil, armodafinil), prazosin and trazodone for the course of the study. 7.Capable of reading and understanding English and able to provide written informed consent to participate. Separate written, signed informed consent will be required if the patient is to participate in the optional pharmacogenomic assessment.
Exclusion criteria
Exclusion criteria: 1. Current or ongoing exposure to the trauma that resulted in the PTSD. 2. Increased risk of suicide on the basis of the Investigator’s judgment and/or the results of the Mini International Neuropsychiatric Interview, Version 7.0.2 (MINI 7.0.2) conducted at Screening and the Columbia Suicide Severity Rating Scale (C-SSRS) conducted at Screening and/or Baseline and Item 10 of the Montgomery-Åsberg Depression Rating Scale (MADRS) at Screening and/or Baseline. Any of the following will be exclusionary: a. High suicidality based on a MINI Module B score = 17 (Screening); or, b. Patient answers YES to either MINI question B10 or B11 (Screening); or, c. Patient meets criteria for CURRENT Suicidal Behaviour Disorder on the MINI (Screening); or, d. C-SSRS Type 4 or Type 5 ideation within 6 months of Screening or at the Baseline visit; or, e. Any suicidal behaviour in the past 12 months as identified by the C-SSRS at Screening or Baseline. f. A score of > 4 on Item 10 of the MADRS at Screening or Baseline. 3. Increased risk of suicide, based on the Investigator’s judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol. 4. Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history. Based on past history and Investigator’s judgment, patients with mild TBI are eligible. 5. Severe depression suggested by a Screening (Visit 1) MADRS score > 26. Patients with a Screening MADRS score of > 26 may be randomized upon Medical Monitor approval, based on a review of all Screening rating scales and the patient’s psychiatric/medical history. 6. Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the Investigator’s opinion, including a Thyroid Stimulating Hormone (TSH) level > 1.5 times the upper limit of normal and aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper li
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy endpoints listed below are considered key secondary endpoints and will be tested in the following order: • Change from baseline in the CAPS-5 total score evaluated at non-landmark visit(s). • Change from baseline in CGI-S score. • Change from baseline in the SDS total score. A fixed sequence procedure will be applied to the above key secondary efficacy endpoints to adjust for multiplicity and to control for overall type I error. Change from baseline in patients’ quality of sleep using the PROMIS Sleep Disturbance instrument score. • Change from baseline in the disruption of work/school activities assessed using the SDS. • Change from baseline in disruption of social life/ leisure activities assessed using the SDS. • Change from Baseline in the disruption of family life/home responsibilities assessed using the SDS. • Change from baseline in CAPS-5 Arousal and Reactivity (Criterion E) score. • Change from baseline in CAPS-5 Intrusion symptoms (Criterion B) score. • Change from baseline in CAPS-5 Negative Cognition and Mood (Criterion D) score. • Change from baseline in CAPS-5 Persistent Avoidance (Criterion C) score. • Change from baseline in CAPS-5 Sleep Disturbance (item E6) score. • Mean PGIC score. • Proportion of patients with a PGIC score of “much improved” or “very much improved”. • Mean CGI-I score. • Proportion of patients with a treatment response on the CGI-I defined as a CGI-I score of “much improved” or “very much improved”. • Proportion of patients with a Total CAPS-5 score of 0 –10 (asymptomatic/few symptoms). • Proportion of patients with a Total CAPS-5 score of 0-22 (asymptomatic or mild PTSD/subthreshold). • Proportion of patients with Response, defined as a = 10-point improvement from baseline in Total CAPS-5 score. • Proportion of patients with Loss of Diagnosis, defined as Response AND no longer meeting DSM-5 symptom criteria in any one or more of the four clusters (B, C, D, E) | — |
Countries
Kenya
Contacts
Public ContactStella Gichuru
Project Manager
Outcome results
None listed