An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in PTSD Symptom Severity: PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
Open-label study of brexanolone infusion for the treatment of posttraumatic stress disorder in 20 adult women with PTSD.
Primary Objective:
To determine if brexanolone injection infused intravenously for 24 hours at up to 60 μg/kg/h reduces PTSD symptom severity in a group of non-veteran adult female subjects diagnosed with PTSD as assessed by the change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score and rate of remission at 12-weeks post infusion.
Secondary Objectives
- To evaluate the safety and tolerability profiles of brexanolone in this PTSD patient population as assessed by the incidence of adverse events (AEs), vital sign measurement, the Stanford Sleepiness Scale (SSS) and the Columbia Suicide Severity Rating Scale (C-SSRS).
- To determine the effects of brexanolone in reducing depressive symptoms and improving functional capacity in PTSD patients as assessed by change from baseline in self-assessment Montgomery-Asberg Depression Rating Scale (MADRS-S) total score and Sheehan Disability Scale scores
详细描述
Study Design and Methodology:
Open label study enrolling 20 subjects in which diagnosis of PTSD will be established, PTSD and depressive symptom severity will be assessed with validated psychometric instruments. Patient will be treated with continuous IV infusions of brexanolone at our affiliate hospital, Ascension Seton Medical Center, using an attenuated version of the intravenous dose regimen previously approved by the FDA for postpartum depression. Following infusion, follow-up visits will be conducted for 12 weeks after the infusion. Subjects must remain as inpatients during the study Treatment Period, which is approximately 30 hours in duration (24 hours of treatment and an additional 6 hours for completion of assessments). The Screening Period and Follow Up Period assessments will be conducted on an outpatient basis. Follow Up visits can be conducted via telemedicine.
Screening Period:
The Screening Period begins with the signature of the informed consent form (ICF). Eligibility is determined by applying the inclusion/exclusion criteria. The primary diagnosis of PTSD (associated with non-military trauma) must be established by the Mini International Neuropsychiatric Interview (MINI). A full medical examination, including laboratory tests and family history, will be taken from the subject.
Treatment Period:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has signed an ICF prior to any study-specific procedures being performed
- •Subject is a premenopausal female between 18 and 50 years of age, inclusive
- •Subject has a current diagnosis of PTSD associated with civilian (i.e., non-military) trauma according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI) at the screening visit.
- •PCL-5 total score ≥ 33 at screening and baseline (Day 0)
- •Subject is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead ECG, or clinical laboratory tests
- •Subject agrees to adhere to the study requirements
- •Subject must have a negative pregnancy test at screening and Day 1 prior to the start of study drug infusion
- •Subject is willing at screening to delay the start of any new pharmacotherapy regimens, including antidepressant or anti-anxiety medication, until the study drug infusion and 72-hour assessments have been completed; if the subject is taking psychotropic medications, these must be at a stable dose from 14 days prior to screening until the 72-hour assessments have been completed.
- •Fluency (oral and written) in the language in which standardized tests will be administered.
- •Subject must use one of the following methods of birth control during participation in the study and for 30 days following the end of the study drug infusion:
- •Total abstinence (no sexual intercourse)
- •Hormonal contraceptives (birth control) including birth control pills, implantable or injectable contraceptives (Norplant® or DepoProvera®)
- •A barrier form of contraception such as a condom or occlusive cap with a spermicide
- •An intrauterine device
排除标准
- •Subject is currently pregnant, breastfeeding, or postpartum less than 6 months since end of pregnancy
- •Subject has renal failure requiring dialysis or fulminant hepatic failure or is anemic (hemoglobin ≤10 g/dL)
- •Known allergy to progesterone or allopregnanolone or any other neuroactive steroid GABAA receptor modulator.
- •Active psychosis per Investigator assessment
- •At risk for suicide in the opinion of the investigator or answers "yes" to "Suicidal Ideation" Item 4 or 5 on the CSSRS (at the time of evaluation) at the screening visit
- •Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- •History of an active substance use disorder in the 6 months prior to screening. A positive urine drug screen (except benzodiazepines under certain circumstances is exclusionary.
- •History of seizure disorder.
- •Subject has previously been treated with brexanolone or participated in any study employing SAGE-547, SAGE-217, SAGE-324, or SAGE-
- •Concomitant treatment with benzodiazepines or other CNS depressants; initiation of any psychotropic agents within 14 days of screening.
- •Any current or recent medical, psychiatric or social condition which in the investigator's opinion is likely to interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being. This includes (but is not limited to) any clinically significant oncologic, hematologic, endocrine/metabolic, cardiovascular, respiratory, renal, hepatic, gastrointestinal, infectious or
研究组 & 干预措施
Open-Label Infusion of Brexanolone
This is a single arm pilot study of open label brexanolone delivered intravenously over a continuous 60-hour period. Infusions will be administered in a certified healthcare setting in accordance with the Zulresso™ dosing, administration and safety guidelines.
干预措施: Brexanolone Injection [Zulresso] (Drug)
结局指标
主要结局
Change in PTSD Symptom Severity: PTSD Checklist for DSM-5 (PCL-5)
时间窗: Through study endpoint (Week 12 / Day 90)
The primary efficacy outcome measure is change in PTSD Checklist for DSM-5 (PCL-5) total score from baseline at study endpoint (i.e., Week 12/Day 90). The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD.
次要结局
- Change in PTSD Subscale Symptoms: PTSD Checklist for DSM-5 (PCL-5)(Through study endpoint (Week 12 / Day 90))
- Change in Functional Capacity: Sheehan Disability Scale (SDS)(Through study endpoint (Week 12 / Day 90))
- Change in Depressive Symptoms: Montgomery-Asberg Depression Rating Scale (MADRS)(Through study endpoint (Week 12 / Day 90))
研究者
Donald Jeffrey Newport
Principal Investigator
University of Texas at Austin