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Psychedelic

Psilocybin for Depression

Phase 3
Recruiting
Led By Sharmin Ghaznavi, M.D., Ph.D.
Research Sponsored by Sharmin Ghaznavi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Be 18-55 years of age at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

"This trial will use brain imaging to study how a single dose of psilocybin affects overthinking and the brain activity related to overthinking in people with major depressive disorder."

Who is the study for?
This trial is for adults aged 18-55 with major depressive disorder who haven't improved after trying 1-4 different depression treatments. They must score high on specific depression scales, not have borderline personality disorder, and be able to stop taking current psychotropic meds two weeks before the study starts. Participants need to read well in English, follow the study plan without help, and be right-handed.
What is being tested?
The trial tests how a single dose of psilocybin affects self-focused thinking (rumination) in people with depression. It involves brain scans using fMRI technology before and after treatment to see what changes occur in brain activity related to these thought patterns.
What are the potential side effects?
While not explicitly stated here, common side effects of psilocybin can include nausea, headache, increased heart rate and blood pressure, altered sense of time and reality (hallucinations), mood swings or panic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can complete all study tasks and attend all visits on my own.
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I am between 18 and 55 years old.
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I have been diagnosed with moderate to severe depression for 3 months to 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ)
Change in Resting-State Functional Connectivity
Change in Self-Attribution Task performance
+1 more
Secondary study objectives
Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF)
Change in Cognitive Flexibility Inventory (CFI
Change in Depression Implicit Attitudes Task (IAT)
+9 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%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
25mg Psilocybin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Sharmin GhaznaviLead Sponsor
Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,340 Total Patients Enrolled
191 Trials studying Depression
33,922 Patients Enrolled for Depression
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,538 Total Patients Enrolled
8 Trials studying Depression
860 Patients Enrolled for Depression
~13 spots leftby Jun 2026
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