PACTR202012739471223尚未招募2 期
A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Daily Bedtime TNX-102 SL in Participants with PTSD. (Protocol No. TNX-CY-P308)
Tonix Pharmaceuticals Company0 个研究点目标入组 220 人开始时间: 2020年12月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
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