ISRCTN14487299进行中（未招募）2 期
A Phase IIb multicentre, randomised, double-blind, two-arm trial comparing the efficacy and safety of 25 mg psilocybin plus psychological support versus 5 mg psilocybin plus psychological support in adults with severe generalized anxiety disorder (GAD) (PSiGAD2)
Incannex Healthcare Limited0 个研究点目标入组 96 人开始时间: 2024年9月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
- 主要终点
- The efficacy of two doses of 25 mg psilocybin with psychological support versus two doses of 5 mg psilocybin with psychological support in the reduction of GAD symptoms in participants with severe GAD (who may or may not be taking concurrent selective serotonin reuptake inhibitor (SSRI) antidepressant). This will be calculated by assessing the change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at week 8, irrespective of treatment discontinuation.
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Aged 18 - 70 years
- •Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)/International Classification of Diseases 11th Revision (ICD-11) defined GAD as the primary diagnosis, with severity indicated by a HAM-A score >25
- •Any sex or gender
- •Body Mass Index 18 - 35 kg/m²
- •Medically suitable as determined by screening including a past medical history, family history, drug history, social history, physical examination and investigations, including an electrocardiogram (EEG) and blood tests.
- •Refrain from taking contraindicated or excluded medications, including herbal, complementary or over-the-counter medications, or have safely tapered and washed out from excluded medications in accordance with the washout period specified in the protocol.
排除标准
- •Any clinically significant, untreated or unstable illness (e.g., hepatic, renal or cardiovascular functions)
- •Type 1 diabetes or insulin dependent type 2 diabetes
- •A diagnosis of epilepsy or at significant risk of seizures based on medical history
- •Positive urine drug test for psychoactive substances at in-clinic screening visit or dosing visits
- •Positive alcohol breathalyser test at the in-clinic screening visit or dosing visits
- •Female participants who are pregnant, breastfeeding or of childbearing potential who are unwilling or unable to use a highly effective method of contraception
- •Participation in another clinical trial of an investigational drug within 30 days or 5 half-lives of the drug (whichever is longest) prior to screening
- •Allergy, hypersensitivity or other Adverse Reaction (AR) to previous use of psilocybin, other hallucinogens, rescue medication and their excipients microcrystalline cellulose
- •Anyone with organic brain injury
- •Treatment with any other antidepressant medication other than a currently prescribed permitted SSRI which must be a stable dose (constant for at least 6 months with no plan to increase)
- •Diagnosed with or having a first degree-relative family history of any of the following psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, or other psychotic disorder as assessed during screening
- •Any history of suicide attempts or behaviours as indicated by reporting yes on any item of the Suicide Behaviour Section of the Columbia Suicide Severity Rating Scale (C-SSRS) within the last 5 years
- •History of suicidal ideation with some intent to act within the last 12 months prior to screening; the participant scores yes on item four or item five of the Suicidal Ideation section of the C-SSRS
- •Judged to be of high suicide or self-harm risk following psychological assessment at screening or baseline
- •Judged to be unfit for psilocybin-assisted therapy based on assessments made during psychological support sessions prior to first dosing session
- •Current or recent treatment with prohibited medications
- •History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses
- •History of electroconvulsive treatment (ECT) or transcranial magnetic stimulation treatment, ketamine, or vagal nerve stimulation
- •Current (within 12 months) alcohol or drug abuse identified as moderate or severe during screening through medical history and the Mini International Neuropsychiatric Interview (MINI) 7.0.2
结局指标
主要结局
The efficacy of two doses of 25 mg psilocybin with psychological support versus two doses of 5 mg psilocybin with psychological support in the reduction of GAD symptoms in participants with severe GAD (who may or may not be taking concurrent selective serotonin reuptake inhibitor (SSRI) antidepressant). This will be calculated by assessing the change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at week 8, irrespective of treatment discontinuation.
次要结局
未报告次要终点
研究者
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