ACTRN12623001004651尚未招募2 期
Evaluating the efficacy of psilocybin-assisted psychotherapy in treatment resistant depression (EMPACT): A randomised, double blinded, 4 arm parallel adaptive trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 140
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Diagnosis of a major depressive episode (MDE) in accordance with the Mini International Neuropsychiatric Interview (MINI)
- •Treatment resistant symptoms at Stage II of the Thase and Rush classification: a failure to tolerate minimum of two trials of antidepressant medication at minimum effective therapeutic dose for at least 6 weeks (no exclusion for greater degrees of treatment resistance)
- •Moderate – severe depressive symptoms: HAM-D score of >17 (moderate – severe depression)
- •Demonstrated capacity to give informed consent
- •Willingness and capacity (as judged on assessment by study clinicians) to engage in the therapeutic elements of the study protocol
排除标准
- •Participants who are not able to give adequate informed consent.
- •Current or previously diagnosed psychotic disorder, schizophrenia or bipolar disorder
- •Immediate family member with a diagnosed psychotic disorder
- •Significant history of mania.
- •History of serious suicide attempts in recent years requiring hospitalisation as judged by a study psychiatrist at initial assessment to impact on safety of participation.
- •Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g., diagnosis of borderline personality disorder.
- •Medically significant condition reviewed as unsuitable for the study due to safety reasons, as reviewed by the study investigator. Such as:
- •oUnstable diabetes
- •oModerate – severe hepatic failure
- •oModerate – severe renal failure
- •oSevere cardiovascular disease
- •Participants presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)
- •Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
- •Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- •Moderate to severe previous or current head injury/Traumatic Brain Injury (TBI).
- •Have a history of stroke or Transient Ischemic Attack (TIA).
- •Current drug or alcohol dependence: Moderate (not in early remission in the 3 months prior to enrolment; meets 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or drug use disorder within the 12 months prior to enrolment (meets at least 6 of 11 diagnostic criteria per DSM-5)
- •Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.
- •Participants who do not agree to use an acceptable contraceptive method throughout their participation in the study, if applicable.
- •Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period.
- •Recreational use in last 12 months of psychedelic substances or a history of regular psychedelic use
- •No email access/ability or no willingness to engage in follow up by electronic questionnaires
- •Use of contraindicated medication (outlined further below) including MAOI, SSRI or SNRI: SSRI/SNRI withdrawal for at least one week (4 weeks for fluoxetine), 2 weeks for irreversible MAOI
- •Use within 5 half-lives of any other serotonin-enhancing medication
- •Participants with significant difficulties in English comprehension or communication such as to prevent completion of study materials.
- •BMI <17 or >42
研究者
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