2025-522961-31-01招募中2 期
The Acute and Long-term Impact of Support in Psilocybin Therapy for Depression: The Psilocybin Setting Trial (PSISET)
Kobenhavns Universitet, Koebenhavns Universitet1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年8月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Between group differences (psychotherapy vs basic support) in MADRS score change from baseline to Week 10
研究概览
简要总结
To evaluate the efficacy of psilocybin with psychotherapy compared to psilocybin with basic support on depressive symptoms. To evaluate the effects of psilocybin with psychotherapy compared to standard of care on depressive symptoms.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Informed oral and written consent.
- •Meeting diagnostic criteria for moderate-severe MDD according to the International Classification of Diseases 10 (ICD-10) and The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- •A MADRS total score between 20-60 (both included).
- •Aged 18 years or above
- •Being willing to abstain from other psychotherapeutic or antidepressant treatments until at least the 6-week primary endpoint.
- •Have an identified support person.
排除标准
- •Meeting ICD-10 diagnostic criteria for mental retardation, schizophrenia spectrum, or other psychotic disorders, and bipolar disorders.
- •Concomitant treatment with medication that modulates uridine diphosphate (UDP) or glucuronosyltransferase (UGT).
- •Use of any serotonergic psychedelic drug within the past 10 years or > 25 lifetime uses.
- •Cardiovascular disease, including a history of myocardial infarction, angina pectoris, heart failure (NYHA class ≥ III), prolonged QTc interval (>450 ms/470 ms men/women)
- •Uncontrolled hypertension (systolic blood pressure >150mm Hg, diastolic blood pressure >90 mm Hg*).
- •Females of childbearing potential who are pregnant, breastfeeding or have the intention of becoming pregnant within the next 12 weeks, or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device – IUD, IUS, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
- •Pregnancy (serum human chorionic gonadotropin (hCG) > 3 U/L at inclusion).
- •Hypersensitivity to the active substance or any of the excipients
- •Unable to speak and/or understand Danish
- •Any condition that the investigator feels would interfere with trial participation.
- •No psychotic symptoms of depression or the like.
- •Immediate family history of psychotic disorders or bipolar disorders, including parents and siblings, but not offspring.
- •Any co-morbid psychiatric condition deemed to be incompatible with the safe administration of psilocybin, e.g., inability to establish rapport.
- •Meeting ICD-10 diagnostic criteria for substance use disorder and/or alcohol use disorders.
- •History of suicide attempt or: 1) active suicidal ideation with some intent to act without specific plan (C-SSRS item 4), 2) active suicidal ideation with specific plan and intent (C-SSRS item 5), 3) have a score of ≥ 5 on Item 10 (suicidal thoughts) on MADRS at screening, 4) have any suicidal ideation or thoughts, in the opinion of the study personnel, PI, the support person or close relatives, that present a serious risk of suicidal or self-injurious behavior at any time.
- •Present or former severe neurological disease, including epilepsy and head trauma with loss of consciousness > 30 min.
- •Concomitant treatment against depressive disorder including pharmacotherapies, electroconvulsive therapy, deep brain stimulation, and vagus nerve stimulation. Benzodiazepines and sleep medicine is allowed, except on the day of dosing.
- •Ongoing tapering off antidepressant or any other serotonergic medication. Prescribed medication must have been stopped at least 5 x elimination half-life. Study personnel will not encourage any tapering off.
研究组 & 干预措施
PEX010 Psilocybin Capsules ( 25mg psilocybin)
Test
干预措施: PEX010 Psilocybin Capsules ( 25mg psilocybin) (Drug)
结局指标
主要结局
Between group differences (psychotherapy vs basic support) in MADRS score change from baseline to Week 10
Between group differences (psychotherapy vs basic support) in MADRS score change from baseline to Week 10
Between group differences (psychotherapy vs SoC) in MADRS score change from baseline to Week 10
Between group differences (psychotherapy vs SoC) in MADRS score change from baseline to Week 10
次要结局
- Between group differences in changes in MADRS-S, MDI, GAD-7, PHQ, WHOQOL-BREF, SWLS, MPFI, ECR-SF, TEQ and PSQI from base line to follow-ups
- Between group differences (psychotherapy vs basic support and psychotherapy vs SoC)) in proportion of participants achieving ≥50% re duction in MADRS and remission (MADRS ≤10) at Week 10, 26, and 52
- Correlation between measures of psychothera peutic mechanisms (WAI-SR, PBAT, qualitative interviews), and changes in treatment out comes
- Correlation between measures of the psyche delic experience (MEQ30, 5D-ASC, EBI, CEQ, PMQ-SF, SDI-A, PEQ, qualitative interviews) and changes in treatments outcomes
- Correlation between blood biomarkers (e.g., BDNF, inflammatory markers) and changes in treatment outcomes
- Assessment of psychotic symptoms, suicidality, worsening of depressive symptoms and adverse events at follow-ups
研究者
Sarah Sonja Hugger
Scientific
Koebenhavns Universitet
研究点 (1)
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