NCT07582120尚未招募2 期
A Pilot Mechanistic Study of Psilocybin-Assisted Therapy as a Treatment for Depression
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Depression is the leading cause of disability worldwide, affecting an estimated 300 million people. Despite available treatments, response rates remain modest, and treatment resistance is common. Novel treatments are needed that act rapidly, produce lasting effects and work differently than existing antidepressants.
In clinical trials, psilocybin has shown promise as a treatment for depression due to its rapid onset of antidepressant effects and sustained benefits.
This study will use MRI scanning of the brain and other biological measures (biomarkers) to investigate how psilocybin affects brain activity and psychological flexibility before, during, and after receiving psilocybin in participants with depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Participants of childbearing potential must agree to practice 2 forms of effective birth control throughout the duration of the study
- •Females of childbearing potential must have a negative urine pregnancy test at Screening and prior to dosing on Dosing Day
- •Diagnosis of depression at Screening via the SCID-5-CT interview and MADRS score of ≥7
- •Have an identified support person Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
排除标准
- •Unable to read or understand English
- •Is currently pregnant or breastfeeding, or plan to become pregnant or breastfeed within the study period
- •Has had Electroconvulsive Therapy, Transmagnetic Stimulation, Vagus Nerve Stimulation or Deep Brain Stimulation treatment within the last 12 months
- •a. Participants with VNS or DBS devices in place- including devices that are inactive or turned off will not be eligible to participate in the imaging portion of the study
- •Is currently taking a medication on the prohibited medications list, such as heterocyclic (tricyclic, tetracyclic) antidepressants, monoamine oxidase inhibitors (MAOIs), antipsychotic augmentation therapy, or is taking more than one medication for the treatment of depression:
- •Participants who are taking a single prescription medication for depression must be on a stable, minimally therapeutic/tolerated dose for at least 4 weeks prior to Screening.
- •Psychostimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) are allowed, if used at a stable dose or pattern for at least 6-weeks prior to Screening and not used on Dosing Day(s).
- •Has a primary psychotic disorder diagnosis
- •Has a first-degree relative with a known history of a psychotic disorder
- •Meets criteria for substance use disorder or diagnosis of substance use disorder within 6 months prior to Screening
- •Has an unstable medical condition or serious abnormalities of complete blood count, chemistries, or ECG, or taking medications that in the opinion of the study clinician would preclude safe participation in the trial
- •Is at risk for hypertensive crisis defined as:
- •BP at Screening AND Baseline >140/90 mmHG
- •BP on Dosing Day prior to dosing >140/90 mmHG
- •Has used a serotonergic hallucinogenic substance (e.g., psilocybin, lysergic acid diethylamide (LSD), mescaline, N,N-dimethyltryptamine (DMT), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 3,4-methylenedioxymethamphetamine (MDMA), or other related substances) within 6 months of Screening.
- •Has a known sensitivity to psychedelic medications
- •Has a positive urine drug test including amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, methamphetamine (unless prescribed), MDMA, methadone, opiates, and phencyclidine (PCP)
- •Is at high risk for suicide (e.g., active suicidal ideation and or current intent or plan) and unable to be managed safely (i.e., unwilling to be hospitalized)
研究组 & 干预措施
25mg Open Label dose of synthetic psilocybin
Experimental
干预措施: Psilocybin (Usona Institute) (Drug)
研究者
Ginger E Nicol
Principal Investigator
Washington University School of Medicine
研究点 (1)
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