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Psychedelic

Psilocybin for Major Depressive Disorder

Phase 2
Waitlist Available
Led By Joshua D Rosenblat, MD, MSc
Research Sponsored by Brain and Cognition Discovery Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights

Study Summary

This trial is testing if psilocybin is safe and if it can help with depression. They will track changes in suicidal thoughts, side effects, and depression symptoms.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of the study based on adverse events
Denture Retention
Feasibility of the study based on suicidal ideation and behaviour scores
Secondary outcome measures
Brief Psychiatric Rating Scale (BPRS)
Clinical Global Impressions Scale (CGI)
Clinician-Administered Dissociative States Scale (CADSS), 23-item
+21 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

2Treatment groups
Experimental Treatment
Group I: Immediate treatmentExperimental Treatment1 Intervention
Participants will commence psilocybin treatment immediately upon study enrollment.
Group II: Delayed treatmentExperimental Treatment1 Intervention
Participants will commence psilocybin treatment two weeks after study enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Brain and Cognition Discovery FoundationLead Sponsor
7 Previous Clinical Trials
1,265 Total Patients Enrolled
Usona InstituteOTHER
12 Previous Clinical Trials
728 Total Patients Enrolled
Braxia Scientific Corp.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who does this clinical trial hope to enroll as participants?

"This study is looking for 30 individuals aged 18-65 who have unipolar depression. Candidates must meet the following conditions: Currently experiencing a major depressive episode without any psychotic features that has lasted for at least 3 months;, A diagnosis of major depressive disorder or bipolar II disorder from a healthcare professional;, Failed to respond to two different guideline-concordant pharmacological treatments for the current MDE, as determined by the Massachusetts General Hospital-Antidepressant Treatment History Questionnaire;, Be able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and comply with all study visits., No history of"

Answered by AI

Has Psilocybin been federally recognized as a safe and effective medication?

"Psilocybin's safety is estimated to be a 2. This is because Phase 2 trials, of which this is one, support the substance's safety but not its efficacy."

Answered by AI

Are there other scientific investigations being conducted that use Psilocybin?

"At the moment, 37 clinical trials are researching Psilocybin with none of them in Phase 3. Most of these studies taking place in Vancouver and Washington but there are 40 locations total running these sorts of investigations."

Answered by AI

How many patients are participating in this trial?

"As of now, this trial has finished recruiting patients. The study was posted on November 19th 2021 and last edited on March 2nd 2022. For those looking for similar studies, there are 1360 trials for unipolar depression and 37 trials concerning Psilocybin that are still admitting participants."

Answered by AI

Do the age restrictions for this research project allow for octogenarians?

"The age range for this particular study is 18 to 65 years old. Out of the 1341 total clinical trials, 205 are for patients younger than eighteen while 1036 are geared towards an older crowd."

Answered by AI

Are new patients being accepted into this trial at present?

"According to the listing on clinicaltrials.gov, this trial is not currently recruiting patients for participation. The study was initially posted on November 19th, 2021 but was most recently updated on March 2nd, 2022. Although this particular trial has closed recruitment, there are 1,397 other trials that are still enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New York
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Canadian Rapid Treatment Centre of Excellence (CRTCE)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Canadian Rapid Treatment Centre of Excellence (CRTCE): < 24 hours
~9 spots leftby Apr 2025