Psilocybin for Depression

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Depression+1 MorePsilocybin - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether psilocybin is a safe and effective treatment for major depressive disorder and borderline personality disorder.

Eligible Conditions
  • Depression
  • Borderline Personality Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Week 2 to Week 5

Baseline to Week 5
Clinical Global Impression - Severity scale (CGI-S)
Montgomery-Asberg Depression Rating Scale (MADRS)
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)
Week 5
Clinical Global Impression - Improvement scale (CGI-I)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Diphenhydramine
9%Nausea
7%Viral upper resp. tract infection
7%Pain
7%Bronchitis
7%Back pain
4%Suicidal Ideation
4%Diarrhea
4%Depressed mood
4%Influenza
4%Headache
4%Sinus headache
4%Alcohol withdrawal syndrome
4%Depression
4%Insomnia
4%Lower resp. tract congestion
4%Oropharyngeal pain
2%Migraine
2%Oedema
2%Bronchitis bacterial
2%Constipation
2%Pyrexia
2%Hypoesthesia
2%Influenza like Illness
2%Anger
2%Peripheral swelling
2%Mallory-Weiss Syndrom
2%Anemia
2%Thrombocytosis
2%Vomiting
2%Dermatitis contact
2%Eye infection
2%Fungal infection
2%Gingivitis
2%Traumatic lung injury
2%Hyponatremia
2%Arthralgia
2%Musculoskeletal pain
2%Pain in extremity
2%Malignant melanoma
2%Dizziness
2%Sedation
2%Anxiety
2%Restlessness
2%Cough
2%Rhinorrhea
2%Sinus congestion
2%Sexual abuse
2%Arthoscopic surgery
2%Endodontic procedure
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Diphenhydramine ARM group. Side effects include: Nausea with 9%, Viral upper resp. tract infection with 7%, Pain with 7%, Bronchitis with 7%, Back pain with 7%.

Trial Design

1 Treatment Group

Experimental: Psilocybin
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Psilocybin · No Placebo Group · Phase 2

Experimental: Psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~560

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 2 to week 5

Who is running the clinical trial?

University of ChicagoLead Sponsor
927 Previous Clinical Trials
754,002 Total Patients Enrolled
16 Trials studying Depression
11,097 Patients Enrolled for Depression
Usona InstituteOTHER
11 Previous Clinical Trials
484 Total Patients Enrolled
6 Trials studying Depression
352 Patients Enrolled for Depression
Jon E Grant, MD, JD, MPHPrincipal InvestigatorUniversity of Chicago
8 Previous Clinical Trials
443 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with current major depressive disorder.
You have borderline personality disorder.

Who else is applying?

What state do they live in?
Illinois34.9%
Indiana6.0%
California4.8%
Other54.2%
How old are they?
18 - 6598.8%
65+1.2%
What site did they apply to?
University of Chicago100.0%
What portion of applicants met pre-screening criteria?
Met criteria89.0%
Did not meet criteria11.0%
Why did patients apply to this trial?
  • "I like to study what medications do and truly believe nature heals!"
  • "I’ve tried other drugs that didn’t work and I’ve heard very positive changes in brain chemistry from microdosing and guided psychedelics."
  • "Hello, I was diagnosed with borderline personality about five months ago. I have struggled with alcoholism and depression most of my adult life. Fortunately, I was able to stop drinking a couple of years ago but the anger, sadness and chaotic relationships continued. About five months ago, I decided to see my first psychologist and she has helped me determine the root cause of all of my problems to be borderline personality disorder. DBT therapy takes years to master and doesn’t address what caused me to develop this disorder in the first place. I have recently begun reading about Psilocybin and think it might be a very good thing for me."
What questions have other patients asked about this trial?
  • "1. How does the waitlist work?"
How many prior treatments have patients received?
050.0%
3+50.0%

How responsive is this trial?

Typically responds via
Email100.0%
Average response time
  • < 2 Days
Most responsive sites:
  1. University of Chicago: < 24 hours
References