NCT05671692暂停2 期
Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans
Christine Marx, MD4 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年9月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Changes in psychological health as measured by the Brief Symptom Inventory-18 (BSI)
研究概览
简要总结
The goal of this clinical trial is to compare pregnenolone and placebo (a placebo is a look-alike substance that contains no active drug) in Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)-Era Veterans with a history of chronic Traumatic Brain Injury (TBI). The main questions it aims to answer are:
- Does pregnenolone improve psychological health, overall physical function, cognition, symptoms of PTSD, and pain more than placebo over the 8-week study period, and what is the most effective dose of the drug that is safe and well-tolerated?
- What are the biological effects of pregnenolone, and how do pregnenolone and other molecules change over the course of treatment? (and do pregnenolone and other molecules predict clinical improvement?)
Participants who are eligible and consent to participate in the study will:
- be randomized in a 1:1 ratio to take pregnenolone or placebo
- be given pregnenolone or placebo to take each day at home
- will participate in 6 visits over 11 weeks for tests, exams and procedures that are for study purposes (each visit will last 1.5 - 3 hours)
- be evaluated at each visit to determine if there are any bad reactions to the study drug and if study participation is still appropriate
- be financially compensated for their visit time and travel cost
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-65 years of age, any ethnic group, either sex.
- •History of mild TBI since 2001 and service in the U.S. Military since 9/11/01 (OEF/OIF/OND era).
- •We will adhere to the operational definition of mild TBI suggested by the World Health Organization Task Force (Holm et al 2005), with the exception of Glasgow Coma Scale score criteria (not available for these participants): a.) 1 or more of the following: confusion or disorientation, loss of consciousness for 30 minutes or less, post-traumatic amnesia for less than 24 hours, and/or other transient neurological abnormalities such as focal signs, seizure, and intracranial lesion not requiring surgery; Glasgow Coma Scale (GCS) score of 13-15 after 30 minutes post-injury or later upon presentation for health care (GCS unavailable). This WHO diagnostic definition of mild TBI is also consistent with the CDC Report to Congress on Mild TBI in the United States, September 2003 (specifically, altered consciousness attributable to the head injury [=transient confusion, disorientation or impaired consciousness] or self-reported loss of consciousness lasting 30 minutes or less).
- •Ability to read/understand English and to participate fully in the informed consent process.
- •No anticipated need to alter psychiatric or pain medications for duration of study involvement.
- •No changes in psychotropic or behavioral interventions during the study or in the 2 weeks prior to study enrollment.
- •Negative pregnancy test if female. Sexually active subjects are required to use a medically acceptable form of birth control if they are of childbearing potential and could become pregnant during the study.
排除标准
- •Exclusionary criteria will diverge slightly from the above WHO definition of mild TBI and exclude participants who report a history of seizures for this investigation.
- •Participants with current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern.
- •Concomitant medications for co-occurring medical conditions are permissible for stable medical conditions that are reasonably well-controlled (for example, hypertension medications, statins, and oral hypoglycemic medications would generally be permissible if they appear to be effectively treating the underlying condition). Medications that could potentially confound study outcomes (for example, prednisone) are exclusionary.
- •Participants who report a history of seizures, a history of stroke, a history of prostate cancer (or any other cancer other than non-melanoma skin cancer), a history of myocardial infarction, the presence of congestive heart failure, or any other serious health condition that would likely preclude safe study participation in the medical opinion of the PI or in consultation with the participant's PCP/other health care provider).
- •Current DSM-5 diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI.
- •Female participants who are pregnant or breast-feeding.
- •Known allergy to study medication.
- •Benzodiazepine or opioid use within the last 2 weeks is exclusionary.
- •Substance use disorder (DSM-5), other than nicotine use disorder.
- •Serious unstable medical illness. History of cerebrovascular accident, prostate, uterine or breast cancer. Medications to treat these conditions either acutely or chronically (for example, finasteride, tamoxifen, clopidogrel) are also exclusionary.
- •Use of oral contraceptives or other hormonal supplementation such as estrogen or progesterone, as there is a theoretical risk that a metabolite of pregnenolone could potentially impact efficacy of oral contraceptives and estrogen replacement.
研究组 & 干预措施
Pregnenolone
Active Comparator
干预措施: Pregnenolone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in psychological health as measured by the Brief Symptom Inventory-18 (BSI)
时间窗: Baseline, week 8
The BSI-18 GSI summarizes a respondent's overall level of psychological distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress. The outcome measure is the change in scores before and after treatment (the baseline and Week 8 difference scores).
次要结局
- Changes in physical health as measured by the 36-Item Short Form Health Survey (SF-36)(Baseline, week 8)
- Changes in mental health as measured by the 36-Item Short Form Health Survey (SF-36)(Baseline, week 8)
- Changes in depression symptoms as measured by the Beck Depression Inventory-II (BDI-II)(Baseline, week 8)
- Changes in cognition as measured by the Wechsler Adult Intelligence Scale (WAIS-IV)(Baseline, week 8)
- Changes in cognition as measured by the Stroop Color and Word Test (STROOP)(Baseline, week 8)
- Changes in PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)(Baseline, week 8)
- Changes in pain symptoms as measured by the Brief Pain Inventory (BPI)(Baseline, week 8)
研究者
Christine Marx, MD
Professor
Duke University
研究点 (4)
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