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Psychedelic

Psilocybin for Depression

Phase 2
Waitlist Available
Led By Sharmin Ghaznavi, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
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

Summary

This trial will study the effects of psilocybin on people with major depressive disorder who haven't responded to other treatments.

Who is the study for?
This trial is for adults aged 18-55 with treatment-resistant major depressive disorder (MDD), who have not improved after trying multiple antidepressants. Participants must be right-handed, able to read well, and have stopped all antidepressant medications at least two weeks before the study starts. They should also be under ongoing mental health care.Check my eligibility
What is being tested?
The study tests how a single dose of psilocybin affects self-focused thought patterns in people with MDD resistant to standard treatments. It involves brain scans (fMRI) to see changes in brain activity related to these thought processes.See study design
What are the potential side effects?
Psilocybin can cause headaches, nausea, increased heart rate and blood pressure, psychological distress or confusion during the experience ('bad trip'), and potential temporary changes in perception or mood.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ)
Change in Resting-State Functional Connectivity
Change in Self-Attribution Task performance
+1 more
Secondary outcome measures
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
Other outcome measures
Change in Brief Fear of Negative Evaluation Scale - Second Version (BFNE-II)
Change in Personal Space Task
Change in Self-Consciousness Scale (SCS)
+3 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%
Oropharyngeal pain
4%
Suicidal Ideation
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%
Rhinorrhea
2%
Musculoskeletal pain
2%
Oedema
2%
Pyrexia
2%
Peripheral swelling
2%
Restlessness
2%
Vomiting
2%
Fungal infection
2%
Hypoesthesia
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

1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
25mg of Psilocybin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include pharmacotherapy and psychotherapy. Pharmacological treatments often involve antidepressants such as SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), and tricyclic antidepressants, which work by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain. Psilocybin, a serotonin receptor agonist, binds to serotonin receptors, potentially leading to rapid and sustained antidepressant effects. Psychotherapeutic approaches like Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) focus on altering negative thought patterns and improving interpersonal relationships. Understanding these mechanisms helps patients and clinicians choose the most appropriate treatment, potentially leading to better outcomes and personalized care.
Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,678 Total Patients Enrolled
187 Trials studying Depression
32,369 Patients Enrolled for Depression
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,558 Total Patients Enrolled
9 Trials studying Depression
880 Patients Enrolled for Depression
Sharmin Ghaznavi, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05381974 — Phase 2
Depression Research Study Groups: Psilocybin
Depression Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05381974 — Phase 2
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05381974 — Phase 2
Depression Patient Testimony for trial: Trial Name: NCT05381974 — Phase 2
~0 spots leftby Jul 2025