An Open Label Trial of Inhaled N,N-Dimethyltryptamine in Patients With Partial Response in Depression.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in MADRS scores
研究概览
简要总结
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
详细描述
This is a phase II open-label, single-ascending, fixed-order study to assess the feasibility and efficacy of inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in current treatment for depression with a partial response.
排除标准
- •heart failure
- •liver failure
- •kidney failure
- •uncontrolled high blood pressure
- •history of heart rhythm disorders
- •history of valvular heart disease
- •history of chronic obstructive pulmonary disease (COPD)
- •active or in treatment for bronchial asthma
- •severe obesity
- •coagulation disorders
- •clinical evidence or history of increased intracranial
- •clinical evidence or history of cerebrospinal pressure
- •history or reports of epilepsy
- •severe neurological disease
- •pregnancy
- •reported or clinically recognized thyroid disorders
- •diagnosis or family suspicion of genetic monoamine deficiency oxidase
- •previous adverse response to psychedelic substances
- •symptoms or family members with a present or past psychotic disorder
- •dissociative identity disorder
- •bipolar affective disorder
- •prodromal symptoms of schizophrenia
- •problematic use or abuse of alcohol or other psychoactive substances (except tobacco)
- •acute or subacute risk of suicide
- •acute flu symptoms
- •symptoms of airway infection
- •contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days
研究组 & 干预措施
N,N-Dimethyltryptamine
Administration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 1-hour dose interval.
干预措施: N,N-Dimethyltryptamine (Drug)
结局指标
主要结局
Change in MADRS scores
时间窗: 7 days
Change in MADRS scores from baseline to 7 days after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression.
次要结局
- Change in PHQ-9 scores(7 days)
- Change in BSI scores.(1 day)
- Change in MADRS scores 14 days(14 days)
- Change in MADRS scores 1 month(1 month)
- Change in MADRS scores 3 months(3 months)
研究者
Draulio Barros de Araujo
Professor
Universidade Federal do Rio Grande do Norte