Psilocybin and Depression - Assessing the Long-term Effects of a Single Administration of Psilocybin on the Psychiatric Symptoms and Brain Activity of Patients With Severe Depression
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- The 16-Item Quick Inventory of Depressive Symptomatology (QIDS)
研究概览
简要总结
The main aim of the study is to investigate the possible long-term therapeutic effects of psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying these changes. Depression severity is assessed before and after (i.e., 1 week, 3 months and 6 months after) a single dose of psilocybin and compared to respective scores of a group receiving an active placebo, ketamine. Brain activity (using functional magnetic resonance imaging) is measured before and one week after drug administration in order to determine whether changes in brain networks related to emotional and self-referential processing correlate with any observed changes in depression scores. Further, blood samples will be obtained from the participants and analyzed in order to reveal gene expression and molecular level correlates underlying rapid antidepressant effects, and to identify biomarkers that predict treatment outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Since the psilocybin is ingested orally in capsule form, whereas ketamine is administered intranasally, the participants will either receive a placebo capsule containing microcrystalline cellulose (if they belong to the group receiving ketamine), or intranasally administered saline solution (with added bitter flavoring which will mimic the taste of ketamine that is often detectable even when administered intranasally).
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depression of a moderate to severe degree (17+ on the 21-item HAM-D).
- •No health-related contraindications.
排除标准
- •Current or previously diagnosed psychotic disorder.
- •Immediate family member with a diagnosed psychotic disorder.
- •Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.).
- •History of suicide attempts.
- •History of mania.
- •Current 5-HT2A antagonist antidepressant medication.
- •Blood or needle phobia.
- •Positive pregnancy test.
- •Current drug or alcohol dependence.
- •Lack of appropriate use of contraception.
- •Breast-feeding.
研究组 & 干预措施
Psilocybin group
This group will receive a single oral 25mg dose of psilocybin under surveilled and safe conditions.
干预措施: Psilocybin (Drug)
Ketamine group
This group will receive a single intranasal 125mg dose of ketamine under surveilled and safe conditions.
干预措施: Ketamine (Ketalar) (Drug)
结局指标
主要结局
The 16-Item Quick Inventory of Depressive Symptomatology (QIDS)
时间窗: 6 months
The primary outcome measures in this study will be the mean change in QIDS scores from pre-administration baseline at day 1 to Follow-up 2 at day 103 (3 months after the administration session). Additionally, an electronic version of the QIDS will be performed 6 months after the administration session. The criteria for determining response will be a reduction of 25% in the (QIDS; Rush et al., 2003) scores from baseline (screening), and remission will be scores of ≤5 on the QIDS.
次要结局
- The Montgomery and Asberg Depression Rating Scale(3 months)
- Hamilton Depression Rating Scale(3 months)
研究者
Jesper Ekelund
Professor of Psychiatry
University of Helsinki