NCT06656702招募中1 期
Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis
Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年4月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility of psilocybin treatment as assessed by number of participants recruited, retained and adhere to treatment
研究概览
简要总结
This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population.
详细描述
The proposed research's primary objective is to study the feasibility of psilocybin therapy for patients with ALS with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population. The proposed proof-of-concept interventional trial will use a single-arm design. The study will be an open-label trial in a sample of up to 24 treatment-seeking patients with a diagnosis of ALS and depressed mood. Participants will complete an 8-week course of study treatment including two psilocybin sessions (15 mg in week 4 and 15 or 25 mg in week 6), with follow-up assessments 1, 3, and 6 months after the final psilocybin session.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older.
- •Patients must fulfill ALS El Escorial criteria for possible, probable, laboratory supported probable or definite ALS.
- •Patients with a pulmonary forced vital capacity (FVC) >50%. The investigators have chosen this measure of function to account for respiratory decompensation during the 6-month longitudinal portion of the study.
- •Patients with ability to swallow tablets by mouth. Participants may have a feeding tube, but must be able to swallow by mouth and cannot use the feeding tube to administer the psilocybin tablet.
- •Clinically significant depressive symptoms as evidenced by an Assessment of Depression Inventory (ADI)-12 score >22.
排除标准
- •Patients with severe speech impairments, including those who are nonverbal, require assisted speech devices, and those who can only communicate by writing or texting.
- •Patients who are unable to consent for themselves.
- •Patients with tracheostomy or continuous continuous positive airway pressure (CPAP) or BiPAP.
- •Known clinical evidence of frontotemporal dementia.
- •Cardiovascular conditions: corrected QT interval (QTc) >450 msec, uncontrolled hypertension (i.e., systolic blood pressure (SBP)> 139 mm Hg, diastolic blood pressure (DBP)> 89 mm Hg), resting heart rate (HR)> 90 beats per minute, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), transient ischemic attack (TIA) in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication).
- •Epilepsy with history of seizures
- •Renal disease (creatinine clearance <40 ml/min using the Cockraft and Gault equation)
- •Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- •Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control (i.e., intrauterine systems/devices, hormonal methods including implant, shot, patch, ring, or oral contraceptive, condom, diaphragm, sterilization, and abstinence).
- •Currently taking medications that interact with psilocybin on a regular (e.g., daily) basis: Atypical antidepressants, such as mirtazapine (Remeron), trazodone (Oleptro), vortioxetine (Brintellix), and vilazodone (Viibryd); Tricyclic antidepressants, such as amitriptyline, imipramine (Tofranil), nortriptyline (Pamelor), desipramine (Norpramin), doxepin, trimipramine (Surmontil), and protriptyline (Vivactil); and Monoamine oxidase inhibitors (MAOIs), such as Selegiline (Emsam), tranylcypromine (Parnate), phenelzine (Nardil) and isocarboxazid (Marplan).
- •Currently taking Nuedexta (dextromethorphan/quinidine combination), efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag.
- •Current or history of meeting Diagnostic and Statistical Manual (DSM)-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder
- •Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I disorder.
研究组 & 干预措施
Psilocybin
Other
All subjects will be in the same, open label arm
干预措施: Psilocybin (Drug)
结局指标
主要结局
Feasibility of psilocybin treatment as assessed by number of participants recruited, retained and adhere to treatment
时间窗: 6 months
feasibility will be assessed by participant recruitment, retention, and treatment adherence.
次要结局
- Depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale(Baseline, 1 week post psilocybin session, 1 month post psilocybin session)
- Depressive symptoms as assessed by the and ALS Depression Inventory(Baseline, 1 week post psilocybin session, 1 month post psilocybin session)
- Impact of psilocybin treatment on quality of life as assessed by the EuroQoL 5-dimension, 3-level (EQ-5D-3L) 5-item ALS Assessment Questionnaire(6 months)
- Impact of psilocybin treatment on hopelessness as assessed by the Beck Hopelessness Scale(6 months)
- Impact of psilocybin treatment on function as assessed by the ALS Functional Rating Scale-Revised(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Comparing hypnosis and supportive counselling as psychological treatments for Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisNervous System DiseasesMotor neuron diseaseISRCTN11845385ASLA Onlus51
已完成
2 期
Rapamycin Treatment for ALSAmyotrophic Lateral SclerosisNCT03359538Azienda Ospedaliero-Universitaria di Modena63
尚未招募
1 期
Tofacitinib in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisNCT06689982Beijing Tiantan Hospital12
已完成
3 期
Minocycline to Treat Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisNCT00047723National Institute of Neurological Disorders and Stroke (NINDS)400
Unknown
2 期
A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS)ALSAmyotrophic Lateral SclerosisNCT03272503University of Calgary100