ACTRN12621001097831招募中2 期
An open-label study of the efficacy and feasibility of psilocybin-assisted psychotherapy for treatment-resistant depression (TRD)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
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
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Adults experiencing treatment-resistant unipolar depression, under the care of a psychiatrist, psychologist, physician, or GP.
- •2. Proficient in English.
- •3. Currently living full-time in Victoria.
- •4. Experiencing severe depression as diagnosed by a trial therapist, with use of a clinical interview and the Montgomery –Asberg Depression Rating Scale (MADRS).
- •5. Experiencing depression that has not responded to two or more separate pharmacological interventions during the current depressive episode.
- •6. Treating medical doctor can confirm patient has safely tapered and washed-out current antidepressant pharmacotherapy prior to baseline assessment.
排除标准
- •1. Containdicated medical conditions including: cardiovascular conditions, major CNS disease, hepatic dysfunction, hypercalcaemia risk, epilepsy/seizures, renal insuffiency, diabetes, hypothyroidism.
- •2. Females who are pregnant, breastfeeding, attempting to conceive or not using effective means of contraception
- •3. Weight <40kg
- •4. Taking a contraindicated medication that cannot be ceased for an appropriate length of time during the trial (may include opioids, metabolic inducers or inhibitors, drugs with a low therapeutic index, and antidepressant medications)
- •5. MRI contraindications
- •6. Any significant, uncorrected visual impairments. This is necessary as some of the cognitive and social processing tasks require visual inspection of stimuli.
- •7. Extremely severe depression/anxiety/suicidality symptoms warranting immediate hospitalisation, as determined by the screening psychiatrist in a clinical interview.
- •8. Current, past history or 1st degree relative with schizophrenia, psychotic disorder (unless induced by substance or medical condition), or Bipolar I/II, as determined by the screening psychiatrist in a clinical interview.
- •9. Current or past (5 year) history of alcohol of substance use disorder (excluding caffeine and nicotine), as determined by the screening psychiatrist in a clinical interview and with the use of the DAST-10 and AUDIT.
- •10. Current Dissociative disorder, Anorexia Nervosa, Bulimia Nervosa or other condition judged to be incompatible with establishment of rapport of safe psilocybin administration as determined by the screening psychiatrist.
研究者
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