Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
Treatment Resistant Depression
About this trial
This is an interventional treatment trial for Treatment Resistant Depression focused on measuring psilocybin
Eligibility Criteria
Key Inclusion Criteria: Aged ≥18 years at Screening Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5]) If the current major depressive episode is the participant's first lifetime episode of depression, the length of the current episode must be ≥3 months and ≤2 years at Screening MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ At Screening, agreement to discontinue all prohibited medications Key Exclusion Criteria: Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder as assessed by a structured clinical interview (MINI 7.0.2) Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa as assessed by medical history and a structured clinical interview (MINI 7.0.2) Psychiatric inpatient within the past 12 months prior to Screening Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode Transcranial magnetic stimulation within the past six months prior to Screening Current enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 30 days prior to Screening Exposure to COMP360 psilocybin therapy prior to Screening
Sites / Locations
- Catalina Research Institute, LLCRecruiting
- Pacific Clinical Research Management Group, LLCRecruiting
- Innovative Clinical Research, Inc.Recruiting
- Behavioral Clinical Research, Inc.Recruiting
- Health Synergy Clinical ResearchRecruiting
- University South FloridaRecruiting
- Atlanta Center for Medical ResearchRecruiting
- iResearch AtlantaRecruiting
- Hassman Research InstituteRecruiting
- Princeton Medical InstituteRecruiting
- University of Cincinnati, Department of Psychiatry & Behavirol NeuroscienceRecruiting
- The Ohio State UniversityRecruiting
- Suburban Research AssociatesRecruiting
- The University of Texas at Austin - Dell Medical SchoolRecruiting
- Seattle Neuropsychiatric Treatment CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
25 mg COMP360 Psilocybin
10 mg COMP360 Psilocybin
1 mg COMP360 Psilocybin
25 mg COMP360 Psilocybin
10 mg COMP360 Psilocybin
1 mg COMP360 Psilocybin, active comparator