Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinician Administered PTSD Scale for DSM-5 (CAPS)
研究概览
简要总结
The purpose of this study is to test the drug CORT108297, which blocks the hormone cortisol, for treatment of PTSD in Veterans, and establish a safety profile that will inform the design of future studies.
详细描述
This is a randomized, double-blind, placebo-controlled Phase IIa clinical trial to test the efficacy and safety of CORT108297- 180mg daily for 7 days for PTSD symptoms in Veterans. Each of the two sites will enroll 44 Veterans with chronic PTSD. Participants first will undergo screening procedures, including a clinical psychological interview, self-report questionnaires, blood draw, and medical evaluations. If eligible, they will be randomized to either CORT108297 or placebo. The same procedures will be repeated at several in-person and virtual visits before, during and after taking the study drug or placebo for seven days. The key outcome measures will be obtained at baseline, day 7, 28, and day 56.
There is large body of evidence demonstrating that Posttraumatic Stress Disorder (PTSD) is associated with alterations in the stress hormone cortisol. There is also evidence that medications that block cortisol may be beneficial for treating PTSD and depression. This study will test a medication, CORT108297, which is from a new class of cortisol blockers which have no effect on other hormones. CORT108297 has been shown to have efficacy in preclinical CNS models and was well tolerated and safe in Phase I healthy volunteer studies making it a candidate for further development. Thus, the goal will be to complete a Phase IIa proof of concept trial of CORT108297 to focus on safety and tolerability and obtain pilot efficacy data to inform the design of future clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of US military service
- •Capable of reading and understanding English
- •Able to provide written informed consent
- •Symptoms of PTSD (must score 23 or greater on the CAPS-5 assessment at screening visit)
- •Men and pre-menopausal women must agree to use two forms of reliable contraception, one of which is a barrier method.
- •Participants who use an SSRI or SNRI medication for PTSD must be on a stable dose for 8 weeks before enrollment.
- •Participants who use trazodone for sleep must be on a stable dose.
- •Participants who use opiate pain medication must be on a stable dose.
- •For participants who are in psychotherapy, treatment must be stable for 6 weeks.
排除标准
- •Alcohol use that meets criteria for Alcohol Use Disorder in past 3 months.
- •Marijuana or other drug use that meets criteria for Substance Use Disorder in past 3 months.
- •Ever diagnosed with: Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Obsessive-Compulsive Disorder, or Major Depressive Disorder with Psychotic Features
- •Experienced any psychologically traumatic event in the past 3 months
- •Currently using certain antidepressant medications such as doxepin or tricyclics
- •Currently using certain mood stabilizers, such as lithium
- •Currently using antipsychotic medication
- •High risk for suicide or violent behavior
- •Has sleep apnea and not using any treatment, such as CPAP
- •Currently using corticosteroid medication (oral or inhaled)
- •History of neurological disease
- •Angina, congestive heart failure or low blood pressure
- •Heart attack in the past 6 months
- •Heart block or irregular heartbeat
- •Kidney failure, liver failure or pancreatitis
- •Severe chronic obstructive pulmonary disease (COPD)
- •History of liver disease with lab results on AST or ALT more than 2 times the normal readings
- •History of kidney disease with lab results on eGFR less than 60 ml/min
- •History of additional risk factors for Torsades de pointes, such as heart failure, low potassium, or family history of a heart rhythm disorder called long QT syndrome
- •Use of certain medications that can affect heart rhythm
- •Use of certain medications that can interfere with the effects of the study drug
- •High blood pressure that is not controlled by medication
- •Diabetes that is not well-controlled
- •History of certain types of head injuries
- •Mild cognitive impairment
研究组 & 干预措施
CORT108297
CORT108297- 180mg daily for 7 days
干预措施: CORT108297 (Drug)
Placebo
Placebo- 180mg daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Clinician Administered PTSD Scale for DSM-5 (CAPS)
时间窗: 56 days
The CAPS is a 30-item interview that is the gold standard assessment for PTSD. The CAPS provides a dimensional and categorical measure of PTSD, and incorporates frequency and intensity of symptoms into a single severity score.
Frequency, Intensity, Burden of Side Effects (FIBSER)
时间窗: 56 days
The FIBSER is a self-report 0-6 Likert-type scale that measures global frequency, intensity, and overall burden of side effects.
次要结局
- PTSD Checklist for DSM-5(56 days)
- Columbia Suicide Severity Rating Scale(56 days)
- World Health Organization Quality of Life (WHOQOL-BREF)(56 days)