CTIS2023-505268-12-00招募中1 期
A Phase III, multicentre, randomised, double-blind, controlled study to investigate the efficacy, safety, and tolerability of two initial administrations of COMP360 in participants with treatment-resistant depression - COMP 006
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 556
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Aged =18 years at Screening, Major depression without psychotic features, If the current major depressive episode is the participant’s first lifetime episode of depression, the length of the current episode must be =6 months and =2 years at Screening, MADRS total score =20 at Screening and Baseline, TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode, Successful discontinuation of all prohibited medications at least two weeks prior to the Baseline visit (if applicable), Please refer to the Protocol for the full list of inclusion criteria
排除标准
- •Prior or ongoing bipolar disorder, any psychotic disorder, or antisocial personality disorder, Clinically significant results on vital signs, ECG, or physical examination at Screening or Baseline, or laboratory tests at Screening, Please refer to the Protocol for the full list of exclusion criteria, Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity, Borderline personality disorder, Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa, Psychiatric inpatient within the past six months prior to Screening, Use of all invasive somatic treatments during the current depressive episode, Use of all non invasive somatic treatments within the past six months prior to Screening, Current enrolment in a psychological therapy programme that will not remain stable, Alcohol or substance use disorder within the 12 months prior to Screening, Exhibiting significant suicide risk, Lifetime exposure to psychedelics with therapeutic intent., Depression secondary to a medical or drug-related cause in the opinion of the Investigator, Exposure to psilocybin, or any other classic psychedelics during the past year or current depressive episode, and agreement not to use psychedelics for the duration of the study follow up, Participants who are pregnant, nursing, or planning a pregnancy, Cardiovascular conditions, Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus, Unstable existing thyroid disease/disorder, Positive urine drug screens for illicit drugs or drugs of abuse at Screening will be reviewed with participants to determine the pattern of use
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