← Back to Search

Psychedelic Therapy

Psilocybin for Depression

Phase 1

Recruiting

Led By Gabrielle Agin-Liebes, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to orally ingest pills for psilocybin dosing visit.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the safety and effectiveness of using psilocybin treatment in individuals with psychiatric symptoms that cause functional impairment. The researchers want to see if these individuals will experience a reduction in symptoms

Who is the study for?

This trial is for individuals with psychiatric symptoms causing functional impairment, such as mood, anxiety, trauma-related or addictive behaviors. Participants must be able to take oral pills, refrain from certain medications on dosing day, and have reliable transportation post-dosing. They should not be starting new psychiatric meds within 4 weeks after dosing.

What is being tested?

The study tests the safety and impact of a single dose of psilocybin (25mg) on various psychiatric symptoms and functional impairments. It's an open-label trial where participants know they're receiving psilocybin, followed by assessments at 1 week, 4 weeks, and 6 weeks post-dose.

What are the potential side effects?

Possible side effects of psilocybin may include changes in perception, altered sense of time and space, emotional shifts ranging from euphoria to distress; physical effects like nausea or dizziness could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can swallow pills by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events Log

Columbia-Suicide Severity Rating Scale (C-SSRS)

Secondary study objectives

Alcohol Use Disorders Identification Test (AUDIT)

Beck Anxiety Inventory (BAI)

Beck Depression Inventory (BDI-II)

+33 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-labelExperimental Treatment1 Intervention

Psilocybin will be administered in an opaque, size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5. The dose of psilocybin will be 25 mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~530

0 / 1Eligibility criteria met