CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial

Section for Affective Disorders; Northern Stockholm Psychiatry4 个研究点分布在 1 个国家目标入组 100 人2024年4月19日

适应症MDD

干预措施psilocybin 25 mg sod psilocybin 1 mg sod

概览

阶段: 2 期
干预措施: psilocybin 25 mg sod
疾病 / 适应症: MDD
发起方: Section for Affective Disorders; Northern Stockholm Psychiatry
入组人数: 100
试验地点: 4
主要终点: MADRS at day 42
状态: 招募中
最后更新: 19天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is:

The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9)

≥10), >1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives).

注册库

clinicaltrials.gov

开始日期

2024年4月19日

结束日期

2026年12月1日

最后更新

19天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Section for Affective Disorders; Northern Stockholm Psychiatry

责任方

Sponsor

入排标准

入选标准

•signed informed consent via minavårdkontakter.se
•Are 20 to 80 (inclusive) years old at the time of signed informed consent
•Are able to read, speak, and understand Swedish
•Are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations
•Are able to swallow capsules
•Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of exposure to the Investigational Product, from Screening through the Day
•A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according to the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10)
•≥1 month after cancer diagnosis and ≥ 12 months of life expectancy at time of inclusion
•physical functioning performance status 0-2 (World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG))
•Meet ICD-10 criteria for a diagnosis of major depressive disorder and are currently experiencing a major depressive episode of at least a 30-day duration at the time of the Screening less than 1 year at time of Screening

排除标准

•Individuals not eligible to be randomized in this protocol are those who meet any of the following criteria:
•Last contact with health care due to cancer monitoring or treatment \>1 year ago.
•Women who are pregnant, as indicated by a positive urine pregnancy test at Screening or Baseline. Women who intend to become pregnant during the study or who are currently nursing.
•Unwilling or unable to discontinue formal psychotherapy
•Ongoing antidepressant drug treatment. No interruption of ongoing antidepressant treatment will be done on the initiation of the study personnel. Patients will be encouraged to discuss any interruption with their responsible clinical physician.
•Have previously during the current episode received the following non-medication treatments: deep brain stimulation (DBS); vagus nerve stimulation (VNS)
•Currently receiving electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
•Unable or unwilling to discontinue any current medications that are known uridine diphosphate (UDP) or glucuronosyltransferase (UGT) enzyme modulators (eg valproate) Note: Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug plus one week at the time of Baseline. See Appendix A for a full list of prohibited medications.
•Report psychedelic substances use ever
•o Note: Psychedelic substances include psilocybin, Lysergic acid diethylamide (LSD), mescaline (and natural products containing mescaline including peyote and San Pedro cactus), N,N-Dimethyltryptamine (DMT), natural products containing DMT including ayahuasca and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 3,4-methylenedioxy- methamphetamine (MDMA) or other psychedelics.

研究组 & 干预措施

psilocybin 25 mg (active)

干预措施: psilocybin 25 mg sod

psilocybin 1 mg

干预措施: psilocybin 1 mg sod

结局指标

主要结局

MADRS at day 42

时间窗: day 42

Montgomery Asberg Depression Rating Scale (MADRS) total score (0-60, smaller equals better)

次要结局

GAD-7 at Day 42(Day 42)
MADRS day 8(day 8)
MADRS-S at all evaluations between Day 0 and Day 42 (Mixed Models for Repeated Measures (MMRM) x1)(Day 42)
SDS at Day 180 (ANCOVA x3)(Day 180)
EQ-5D-5L at Day 90 and Day 180 (ANCOVA x6)(Day 90 and Day 180)
AQOL-6D at Day 90 and Day 180 (ANCOVA x2)(Day 90 and Day 180)
HADS at Day 42(Day 42)
SDS at Day 42(Day 42)
AQOL-6D at Day 42 (ANCOVA x1)(Day 42)
CGI at Day 90 and Day 180 (ANCOVA x6)(Day 90 and Day 180)
CGI at Day 8 and Day 42 (analysis of covariance (ANCOVA) x6)(Day 8 and 42)
MADRS at Day 90 and Day 180 (ANCOVA x2)(Day 90 and Day 180)
MADRS-S at all evaluations between Day 43 and Day 180 (MMRM x1)(between Day 43 and Day 180)
GAD-7 at Day 180 (ANCOVA x3)(Day 180)
EQ-5D-5L at Day 8 and Day 42 (ANCOVA x6)(Day 8 and 42)
HADS at Day 180 (ANCOVA x3)(Day 180)