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).
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- major depressive disorder
- 发起方
- The University of Auckland
- 入组人数
- 20
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
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