An Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics & Exploratory Efficacy of Intravenous SPL026 Drug Product (DMT Fumarate) Alone or in Combination With SSRIs in Patients With Major Depressive Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Safety & tolerability: Lab biochemistry
研究概览
简要总结
The main aim of the study is to test the safety and tolerability of single doses of SPL026 (N,N-dimethyltryptamine [DMT] fumarate, a psychedelic tryptamine) in patients currently taking a selective serotonin reuptake inhibitor (SSRI) for their depression, but for whom the SSRI is not fully relieving their depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •MDD diagnosis
- •Previously tried at least one approved method of treatment for their depression
- •No monoamine oxidase-inhibitor class antidepressants for at least 3 months
- •Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, laboratory tests of blood and urine
- •No psychedelic drug use in the 6 months before dosing until the end of the study
- •Willing to follow the contraception requirements of the trial
- •Willing to be contacted by email and video call, and have online access
- •Able to give fully informed written consent
- •Test Cohort only: currently on a stable dose of an unspecified single SSRI alone and not in combination with any other psychiatric medications, for at least 6 weeks prior to Screening with no intention of making any changes
- •Control Cohort only: no antidepressant medication for 6 months before dosing
排除标准
- •Substance use disorder
- •Current or clinically relevant history of a psychotic disorder, or first-degree relatives with a clinically relevant history of a psychotic disorder
- •Significant history of mania
- •Significant risk of suicide
- •Clinically relevant abnormal findings at the screening assessment
- •Blood pressure, heart rate, or QTcF outside the acceptable ranges
- •Acute or chronic illness (other than MDD) or infection
- •Clinically relevant abnormal medical history or concurrent medical condition (other than MDD)
- •Use of any serotonergic psychedelics within 6 months prior to dosing
- •Patients of child-bearing potential who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception
- •History of a severe adverse reaction to any drug or sensitivity to serotonergic psychedelic drugs
- •Use of over-the-counter or prescribed medication (excluding oral contraceptives, hormone replacement therapy and SSRIs [Test Cohort only]) within previous 28 day before dose of trial medication; or paracetamol or ibuprofen within 4 hours prior to dosing
研究组 & 干预措施
Test Cohort
Patients who are currently taking an SSRI that is not effective in fully relieving their depression (prescribed outside of study). Patients will be administered a single dose of SPL026 by intravenous infusion.
干预措施: SPL026 (Drug)
Control Cohort
Patients who are not currently taking any pharmacological treatment for their depression. Patients will be administered a single dose of SPL026 by intravenous infusion.
干预措施: SPL026 (Drug)
结局指标
主要结局
Safety & tolerability: Lab biochemistry
时间窗: Screening, Day -1 and Day 1
Values of potential clinical importance
Safety & tolerability: Vital signs - Heart Rate
时间窗: Screening to Day 2
Heart rate
Safety & tolerability: Adverse Events
时间窗: Screening to End-of-Study Follow-up (Day 29)
Adverse events (AEs)
Safety & tolerability: Vital signs - Blood pressure
时间窗: Screening to Day 2
Blood pressure
Safety & tolerability: Vital signs - Temperature
时间窗: Screening to Day 2
Temperature
Safety & tolerability: Electrocardiogram
时间窗: Screening to Day 2
QTcX intervals
Safety & tolerability: Suicidal Ideation
时间窗: Screening to End-of-Study Follow-up (Day 29)
Columbia-Suicide Severity Rating Scale
次要结局
- Challenging Experience Questionnaire (CEQ)(Day 1 (dosing day))
- Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)(Day -1, Day 15 and Day 29)
- Evaluation of plasma levels of DMT(2, 5, 7, 10, 11, 13, 15, 30, 60, 120, 240 minutes post-dose)
- Mystical Experience Questionnaire (MEQ)(Day 1 (dosing day))
- Ruminative Responses Scale (RRS)(Day -1 and Day 29)