ACTRN12623000486628已完成2 期
An open-label pilot trial assessing tolerability and feasibility of LSD microdosing in patients with major depressive disorder (LSDDEP1).
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Provision of signed and dated informed consent form.
- •2. Stated willingness to comply with all study procedures and availability for the duration of the study.
- •3. Any gender identity aged, 21-65 years .
- •4. Diagnosis of Major Depressive Disorder (MDD) as per the DSM-5 criteria for MDD
- •5. Have a MADRS score between 18-35 at the time of screening.
- •6. Ability to take oral medication and be willing to adhere to the study intervention regimen.
- •7. For persons of child-bearing potential: agree to use an effective or highly effective contraception
排除标准
- •1. Current or past history schizophrenia or other psychotic disorders, or bipolar I or II disorder
- •2. Diagnosis of PTSD as assessed by clinical interview
- •3. Diagnosis of an eating disorder as assessed by clinical interview
- •4. Risk of suicide as determined by The Columbia-Suicide Severity Rating Scale (C-SSRS).
- •5. Substance dependence in the previous 6 months
- •6. Problematic use of alcohol defined as a score on the AUDIT of 16 or greater.
- •7. Stage II or higher treatment-resistant depression as defined by the Thase and Rush (1997)
- •staging criteria for the current depressive episode.
- •8. BMI <18 and > 35.
- •9. Planned or current pregnancy or lactation.
- •10. Cardiovascular conditions including abnormal heart rate or blood pressure
- •11. Significant renal or hepatic impairment.
- •12. Abnormal 12-lead ECG as judged by a study physician.
- •13. Abnormal laboratory test findings as judged by a study physician.
- •14. Use of monoamine oxidase inhibitors, methylphenidate or dexamphetamine.
- •15. Excessive on-going medication burden as determined by a study physician.
- •16. Any lifetime history of psychedelic microdosing.
- •17. Use of serotonergic psychedelic drugs in the last year.
- •18. Lifetime history of self-medicating with psychedelics to treat their depression.
研究者
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