PEX010 for Mental Depression

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mental Depression+6 More
Psilocybin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting. In order to investigate the effects of length of time on SSRI therapy, 30 participants with varying lengths of time on SSRI therapy will be enrolled, stratified into four groups: Group 1: ≤ 1 year Group 2: 1 to ≤ 5 years Group 3: 5 to ≤ 10 years Group 4: > 10 years

Eligible Conditions
  • Mental Depression
  • Major Depressive Disorder (MDD)
  • Mild Depression
  • Depression
  • Melancholia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mental Depression

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 1 month (week -2 to week +2)

Month 1
Heart rate
Respiratory rate
Sleep disturbances
Time in bed
6 months
Recruitment rate
Week 12
Electroencephalography
Electroencephalography
Montgomery and Asberg Depression Rating Scale (MADRS)
Number of adverse-events (AEs)
Number of serious adverse events (SAEs)
QIDS-SR-16 remission
Strontium
Mental Depression
Month 6
Retention

Trial Safety

Safety Progress

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

Other trials for Mental Depression

Side Effects for

Psilocybin
44%Headache
21%Nausea
15%Anxiety
8%Suicidal Ideation
6%Insomnia
6%Depressed mood
4%Alcohol poisoning
4%Pneumonia
4%Viral upper resp. tract infection
4%Depression
4%Corona virus infection
4%Vomiting
4%Upper respiratory tract infection
4%Abdominal pain upper
2%Musculoskeletal pain
2%Dizziness
2%Pain
2%Limb injury
2%Abdominal pain
2%Blood pressure increased
2%Urinary incontinence
2%Cataract
2%Testicular pain
2%Toothache
2%Illusion
2%Fatigue
2%Psychomotor hyperactivity
2%Skin cosmetic procedure
2%Food allergy
2%Muscle strain
2%Back pain
2%Food poisoning
2%Alcohol withdrawal syndrome
2%Dysphoria
2%Nasal congestion
2%Photopsia
2%Myalgia
2%Palpitations
2%Dyspepsia
2%Biopsy cervix
2%Gingivitis
2%Diverticulitis
2%Asthenia
2%Influenza
2%Oropharyngeal pain
2%Hyperventilation
2%Blood pressure diastolic increased
2%Dyspnea
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Psilocybin ARM group. Side effects include: Headache with 44%, Nausea with 21%, Anxiety with 15%, Suicidal Ideation with 8%, Insomnia with 6%.

Trial Design

1 Treatment Group

PEX010
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: PEX010 · No Placebo Group · Phase 2

PEX010
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

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month (week -2 to week +2)

Who is running the clinical trial?

Cybin Therapeutics Inc.Lead Sponsor
Reginald Peters, MDPrincipal InvestigatorUpstream

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to speak English fluently.
You have a diagnosis of Major Depressive Disorder by a psychiatrist.
You have a score of 7-34 inclusive (mild-moderate) on the MADRS.
You are medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.
Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California50.0%
New York25.0%
British Columbia25.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
What site did they apply to?
Centre for Neurology Studies x Upstream100.0%
Why did patients apply to this trial?
  • "In the past I’ve tried Prozac, Wellbutrin, and Effexor. None of which have really helped."
How many prior treatments have patients received?
3+100.0%