EUCTR2022-000574-26-IE招募中1 期
A randomized, double-blind, placebo-controlled, Phase 2b trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-resistant depression
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
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
- •1. Is in the age range between 18 and 64 years (inclusive) at the time of informed consent.
- •2. Meets the trial criteria for TRD as assessed by a study psychiatrist:
- •a. Meets the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for single-episode MDD or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI) 7.0.2 with current episode duration of =2 years.
- •b. The current MDE must be deemed valid” based upon the Massachusetts General Hospital State versus trait Assessability Face and Ecological validity Rule of 3Ps (MGH SAFER) criteria interview.
- •c. Had nonresponse (=25% improvement) to =2 and =5 oral antidepressant treatments started during the current episode of depression
- •For full details please refer to the Protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has, based on history, psychiatric assessment, and evaluation of the MINI during the screening period, a first MDD episode after age 60, a current or prior diagnosis of a psychotic disorder, MDD, or other mood disorder with psychotic features, bipolar disorder, obsessive compulsive disorder, posttraumatic stress disorder, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, antisocial personality disorder, schizotypal personality disorder, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to a study psychiatrist.
- •2. Has significant suicide risk as defined by (a) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, during the screening period, or at Baseline; or (b) suicidal behaviors within the past year; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within the past year.
- •3. Has 1 or more first degree relatives with a current or prior diagnosis of bipolar disorder, psychotic disorder, or other mood disorder (including MDD) with psychotic features.
- •4.Undergoing systematic psychotherapy (including cognitive behavioral therapy [CBT]) that is planned to be modified or planning to initiate psychotherapy during the trial. CBT must have been ongoing for the last 3 months prior to Baseline.
- •5. Has any current or past clinically significant condition (e.g., severe infection, severe pulmonary disease, uncontrolled hypertension, uncontrolled diabetes, severe cardiovascular disease, valvulopathy, pulmonary hypertension, myocardial infarction, angina or clinically significant arrythmia within the past year, severe hepatic or severe renal failure, brain disorder including seizure, stroke, dementia, aneurysm, history of intracerebral hemorrhage, degenerative neurologic diseases, meningitis, encephalitis, and head injury with loss of consciousness) that may interfere with the interpretation of the trial results, constitute a health risk for the patient, or that otherwise renders the patient unsuitable for the trial according to the investigator’s judgement.
- •6. Fulfils criteria for DSM 5 alcohol or substance use disorder (excluding tobacco and caffeine use disorders) within the preceding 1 year, as assessed via the MINI.
- •7. Takes or has taken disallowed recent or concomitant treatments or it is anticipated that the patient will require treatment with at least 1 of the disallowed concomitant treatments during the trial.
- •8. Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug (e.g., psilocybin, Psilocybe spp. mushrooms, 5 MeO DMT, DMT, ayahuasca, LSD, mescaline) according to the investigator’s judgement.
- •For full details please refer to the Protocol.
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