ISRCTN63465876已完成2 期
A double-blind, randomized, placebo-controlled study of intravenous doses of SPL026 (DMT fumarate), a serotonergic psychedelic, in healthy subjects (Part A) and patients with major depressive disorder (Part B)
Small Pharma Ltd0 个研究点目标入组 68 人开始时间: 2023年8月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
研究概览
简要总结
2023 Funder report results see attached file ISRCTN63465876_FunderReport_V1_20Jun23.pdf [1] (added 18/09/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38274414/ Part A results in healthy volunteers (added 30/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Normotensive male or female, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, laboratory tests of blood and urine, Mini-International Neuropsychiatric Interview (MINI) and Beck Scale for Suicidal Ideation (BSS)
- •2. Willing to follow the contraception requirements of the trial; willing to refrain from psychedelic drug use (excluding the study drug) during the trial and =3 months afterwards
- •3. Willing to be contacted by email and video call, and have online access; able to give fully informed written consent
- •4. Part A only: psychedelic-naïve, ie have never taken a serotonergic psychedelic drug, in any form. Must be 25 years or older
- •5. Part B only: MDD diagnosis (as per DSM-V); not on antidepressant medication or willing to discontinue antidepressant medication (e.g. selective serotonin reuptake inhibitor [SSRI] treatment) for a sufficient time before and during the study
- •6. No psychedelic drug use in the 6 months before dosing
排除标准
- •1. Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception
- •2. Clinically relevant abnormal findings at the screening assessment
- •3. Acute or chronic illness (other than MDD [Part B only]) or infection; clinically relevant abnormal medical history or concurrent medical condition (other than MDD [Part B only])
- •4. Positive tests for hepatitis B & C, or HIV
- •5. Severe adverse reaction to any drug
- •6. Use of over-the-counter or prescribed medication (excluding oral contraceptives) within the previous 28 days (paracetamol [acetaminophen] permitted up to 7 days, and antidepressant medication must have ceased for at least 14 days; 28 days for MOAIs) before the first dose of trial medication
- •7. Drug or alcohol abuse; use of cannabis in the 24 h before each study visit
- •8. Heavy smokers (>10 [Part A] or > 20 cigarettes [Part B] daily)
- •9. Supine blood pressure, heart rate, or QTcF outside the acceptable ranges
- •10. Participation in other clinical trials of unlicensed medicines, or loss of more than 400 ml blood, within the previous 3 months
- •11. Phobia of needles or blood
- •12. Possibility that the volunteer will not cooperate with the study
研究者
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