A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13.
研究概览
简要总结
The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of depressive symptoms, and its dose-related psychoactive effects in patients with Treatment-Resistant Depression (TRD).
The study is comprised of two open-label, single-arm study parts where Part A evaluates single doses of GH001 at two dose levels and Part B evaluates a specific individualized dosing regimen of GH001.
详细描述
Phase 1 (Part A):
The primary objective of this study is to assess the safety and tolerability of single doses of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT) in patients with TRD.
The secondary objectives of the study are to assess the effects of single doses of GH001 on various measures of depression, and on dose-related psychoactive effects.
Phase 2 (Part B):
The primary objective of this study is to assess the effects of an individualized dosing regimen of GH001 on the severity of depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
- •Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI);
- •Treatment-Resistant Depression as evaluated by the Antidepressant Treatment History Form - Short Form (ATHF-SF);
- •Has outpatient status at screening and enrolment visits;
排除标准
- •Has a current or prior diagnosis of a psychiatric comorbidity that renders the patient unsuitable for the study according to a study psychiatrist or registered psychologist;
- •Has received any investigational medication within the last 1 month;
- •Has a current medically significant condition (e.g., severe infection) or has a history of a medically significant condition (e.g., medical history of seizure, uncontrolled hypertension, uncontrolled diabetes, severe cardiovascular disease, hepatic or renal failure, etc.) that renders the patient unsuitable for the study according to the medical supervisor's judgment;
- •Takes any medication or other substance that renders the patient unsuitable for the study according to the medical supervisor's judgment;
- •Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters, which renders the patient unsuitable for the study according to the medical supervisor's judgment;
研究组 & 干预措施
Phase 1 (Part A): GH001 dose A
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Phase 1 (Part A): GH001 dose B
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
Phase 2 (Part B): GH001 Individualized Dosing Regimen
干预措施: 5 Methoxy N,N Dimethyltryptamine (Drug)
结局指标
主要结局
Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13.
时间窗: up to 7 days
Phase 1: The primary endpoint is a binary variable (yes/no) reflecting a combined medical/clinical evaluation of the occurrence of Outcomes 5 to 13. The endpoint will be considered met for any dose level or regimen if the Study Safety Group (SSG) - through a qualitative medical/clinical evaluation - considers that dose level or regimen sufficiently safe and tolerable for potential further clinical development in a subsequent study.
Phase 2: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: up to 7 days
Phase 2: The assessment is done with the Montgomery-Asberg Depression Rating Scale (MADRS), a diagnostic questionnaire with ten items for measuring the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item is scored from 0 to 6. The overall score ranges from 0 to 60.
次要结局
- Phase 2: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13(up to 7 days)
- Phase 1: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)(up to 7 days)