A Phase 2 interventional study of Psilocybin in Treatment Resistant Depression, sponsored by Brain and Cognition Discovery Foundation. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Brain and Cognition Discovery Foundation · Phase 2, Interventional, and Treatment
The purpose of this study is to see if psilocybin, an investigational drug, is safe and well tolerated. Researchers also want to know if psilocybin can improve symptoms of depression. This study will see if psilocybin is safe and well tolerated by tracking changes in suicidal thoughts and behaviour, monitoring if any participants choose to stop participating in the study, and measuring any serious side effects, as well as how long they take to resolve. This study will also see if depression symptoms improve (or worsen) after psilocybin is administered. Additional information about participants' depressive symptoms and side effects will also be measured during the study.
This randomized clinical trial will assess the feasibility, safety, and efficacy of single and repeat doses of psilocybin at point-of-care in persons with treatment-resistant depression as part of major depressive disorder or bipolar II disorder. The primary objective is to evaluate the feasibility of psilocybin in adults with treatment-resistant depression. The secondary objectives are to assess the efficacy and tolerability of psilocybin at point-of-care.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Brain and Cognition Discovery Foundation is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Individuals meeting one or more of the following DSM-5-defined criteria will be excluded:
Individuals meeting one or more of the following criteria will also be excluded:
Participants will commence psilocybin treatment immediately upon study enrollment.
Drug: Psilocybin
Participants will commence psilocybin treatment two weeks after study enrollment.
Drug: Psilocybin
Participants will receive a single dose of psilocybin and be assessed weekly for six weeks and biweekly for 18 weeks. Participants who relapse may receive up to two repeated doses of psilocybin.
Feasibility of the study based on participant retention
Participant drop-out rates will be calculated to determine the feasibility of psilocybin in adults with treatment-resistant depression.
Time frame: Up to 24 weeks
Feasibility of the study based on suicidal ideation and behaviour scores
Feasibility will be judged based on change in Columbia Suicide Severity Rating Scale (CSSRS) scores. The CSSRS evaluates suicidal ideation and behaviour. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Time frame: Up to 24 weeks
Feasibility of the study based on adverse events
Feasibility will be judged based on the percentage of participants experiencing serious adverse events and the percentage of adverse events resolving within 48 hours of each dose administration.
Time frame: Up to 24 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
The MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity.
Time frame: Up to 24 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) response rate
The proportion of participants with at least a 50% reduction in MADRS total score relative to baseline.
Time frame: Up to 24 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) remission rate
The proportion of participants with a MADRS total score of 10 or lower.
Time frame: Up to 24 weeks
McIntyre and Rosenblat Rapid Response Scale (MARRRS)
The MARRS was recently validated in adults with treatment-resistant major depressive or bipolar disorder receiving open-label intravenous ketamine at a community-based treatment center The MARRRS is a self-reported 14-item self-report measure of depressive symptoms present during the past 72 hours. Total score ranges from 0 to 42; a higher score indicates greater symptom severity.
Time frame: Up to 24 weeks
Patient Health Questionnaire 9-item (PHQ-9)
The PHQ-9 is a self-rated measure of depressive symptom severity in the past two weeks. Each of the nine items is rated on a Likert scale, ranging from 0 (not at all) to 3 (nearly every day), and summed for a total score between 0 (no symptoms) to 27 (most severe).
Time frame: Up to 24 weeks
Clinical Global Impressions Scale (CGI)
The CGI severity module assesses the severity of a person's depressive illness using a seven-point Likert scale, ranging from "Normal, not at all depressed" to "Among the most extremely depressed patients". The CGI improvement module evaluates the global improvement of a person's condition since their last visit on a seven-point Likert scale, ranging from "Very much improved" to "Very much worse".
Time frame: Up to 24 weeks
Quick Inventory for Depressive Symptomatology, Self-Report, 16-item (QIDS-SR-16)
The QIDS-SR-16 total score ranges from 0 to 27 with 0 representing no depression and 27 representing severe depression.
Time frame: Up to 24 weeks
Columbia Suicide Severity Rating Scale (CSSRS)
The CSSRS evaluates suicidal ideation and behaviour. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Time frame: Up to 24 weeks
Clinician-Administered Dissociative States Scale (CADSS), 23-item
Total scores on the 23-item CADSS range from 0 to 92; a higher score denotes greater dissociative symptom severity.
Time frame: Up to 20 weeks
Clinician-Administered Dissociative States Scale (CADSS), 6-item
Total scores on the 6-item CADSS range from 0 to 24; a score of 3 or greater denotes the presence of dissociation symptom severity.
Time frame: Up to 20 weeks
Brief Psychiatric Rating Scale (BPRS)
The BPRS rating scale has 18 items, each item rated on a severity scale of 1 (not present) to 7 (extremely severe). 0 is entered if the item is not assessed.
Time frame: Up to 20 weeks
Young Mania Rating Scale (YMRS)
Total scores range from 0 to 60, with higher scores indicative of greater symptom severity.
Time frame: Up to 20 weeks
Mystical Experiences Questionnaire (MEQ)
The MEQ consists of 30 items, each item rated on a Likert scale (0-None/not at all to 5-Extreme, more than any other time in my life). The MEQ total score is computed by taking the average response to all items.
Time frame: Up to 20 weeks
Sheehan Disability Scale (SDS)
The SDS total score ranges from 0 to 30 with 0 representing no impairment and 30 representing severe impairment. The last two items of the scale (Days Lost and Days Unproductive) range from 0 to 7 (higher number denotes greater impairment).
Time frame: Up to 24 weeks
EuroQol-5D 5-Level (EQ-5D-5L)
The EQ-5D-5L consists of 5 items; each item ranges from 1 (no problems) to 5 (extreme problems). A participant's self-rated health is recorded on a vertical visual analogue scale (range 100 to 0), where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0).
Time frame: Up to 24 weeks
World Health Organization-5 Well-Being Index (WHO-5)
The WHO-5 is a measure of overall well-being, rated on a scale of 0 to 25, with higher scores denoting higher quality of life.
Time frame: Up to 24 weeks
World Productivity and Impairment Questionnaire (WPAI)
The WPAI is a six-item self-administered rating scale measuring work absenteeism, presenteeism, and productivity loss and daily activity impairment. Individuals are asked to rate to what extent health problems affected their ability to do regular daily activities other than work at a job (0-No effect on daily activities to 10-Completely prevented me from doing my daily activities). Respondents who are currently employed are additionally asked to rate the number of hours missed from work due to health problems, the number of hours missed due to other reasons (e.g., vacation, time off to participate in this study), and the number of hours worked in the past seven days, as well as to what extent health problems affected productivity while working (0-No effect on my work to 10-Completely prevented me from working). Responses to each question are scaled to an overall percentage score (0 to 100), with higher values denoting greater impairment
Time frame: Up to 24 weeks
Perceived Deficits Questionnaire - Depression - 5-Item (PDQ-5-D)
The total score ranges from 0 to 20, with greater scores indicative of greater subjective cognitive impairment.
Time frame: Up to 24 weeks
Digit Symbol Substitution Test (DSST)
The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within 90 seconds for a total possible score of 0 to 90. A higher score reflects greater performance.
Time frame: Up to 24 weeks
Trail Making Test A (TMT-A)
The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants are asked to connect circles in numerical sequence. If a participant makes a mistake, the administrator points out the error, and the participant must return to the last correct circle and continue the task. Lower scores represent better performance.
Time frame: Up to 24 weeks
Trail Making Test B (TMT-B)
The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants are asked to connect circles in alternating numerical and alphabetical sequence (e.g., 1-A-2-B). If a participant makes a mistake, the administrator points out the error, and the participant must return to the last correct circle and continue the task. Lower scores represent better performance.
Time frame: Up to 24 weeks
Generalized Anxiety Disorder-7 (GAD-7)
Total score ranges from 0 to 21; a higher score denotes greater symptom severity.
Time frame: Up to 24 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
The SHAPS total score ranges from 14 to 56, wherein a higher score indicates greater hedonic capacity (lower anhedonic severity).
Time frame: Up to 24 weeks
Peripheral inflammatory and metabolic biomarkers
Inflammatory, neuroplasticity, and metabolic targets that are hypothesized to be relevant to the therpeutic mechanism of psilocybin in depression (e.g., interleukin-6, brain-derived neurotrophic factor, insulin, leptin).
Time frame: Up to 2 weeks
Plan to share: No
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Brain and Cognition Discovery Foundation