StudyFinder
A Phase III, multicentre, randomised, double-blind, placebo-controlled study to investigate the efficacy, safety, and tolerability of COMP360 in participants with treatment-resistant depression
Status: Recruiting
MM - Study 3 of 6 - Expedited Study
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
• diagnosis of major depression without psychotic features
• if the current major depressive episode is the first episode of depression, the length of the current episode must be at least 3 months and no more than 2 years
• have not responded to an adequate dose and duration of two, three, or four different medications to treat the current episode
• agree to discontinue all prohibited medications (study staff will review)
Exclusion Criteria:
• any additional major mental health diagnosis
• required psychiatric inpatient care in the past 12 months
• treatment with electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
• transcranial magnetic stimulation within the past six months
• in a psychological therapy program that will not remain stable for the duration of the study
Interventions:
Drug: Psilocybin
Conditions:
Mental Health & Addiction
Keywords:
TRD, Treatment Resistant Depression
Contact(s): Interventional Psychiatry Lab Study - ipl@umn.edu
Principal Investigator: Ziad Nahas
Phase: PHASE3
IRB Number: STUDY00020807
System ID: 40285
See this study on ClinicalTrials.gov