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Psychedelic

PEX010 for Depression

Phase 2
Waitlist Available
Led By Reginald Peters, MD
Research Sponsored by Cybin Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month (week -2 to week +2)
Awards & highlights

Study Summary

This trial investigates how psilocybin affects depression, stratifying participants based on length of time on SSRI therapy.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month (week -2 to week +2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month (week -2 to week +2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mental Depression
Secondary outcome measures
Montgomery and Asberg Depression Rating Scale (MADRS)
Number of adverse-events (AEs)
Number of serious adverse events (SAEs)
+4 more
Other outcome measures
Electroencephalography
Electroencephalography
Heart rate
+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%
Suicidal Ideation
4%
Oropharyngeal pain
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%
Restlessness
2%
Fungal infection
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Peripheral swelling
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: PEX010Experimental Treatment1 Intervention
25mg of PEX010 (one-time administration)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Cybin Therapeutics Inc.Lead Sponsor
Reginald Peters, MDPrincipal InvestigatorUpstream

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the patient eligibility for this study restricted by age?

"According to the criteria for inclusion, participants must be between 19 and 65 years of age. Patients younger than 18 can look into 405 alternative studies while seniors over 65 are eligible for 1456 other trials."

Answered by AI

Has PEX010 been sanctioned by the U.S. Food and Drug Administration?

"Taking the evidence into consideration, our team at Power assigned a score of 2 for PEX010's safety since it has not yet been proven efficacious but there is some data attesting to its security."

Answered by AI

Are researchers enrolling participants in this investigation at present?

"Based on the information posted to clinicaltrials.gov, this clinical trial is not currently accepting patients. First published on December 15th 2022 and last updated October 25th of that same year, it does not appear any new candidates are required for now; however, there remain 2033 other trials seeking participants at present."

Answered by AI

Are there any criteria that would disqualify me from participating in this research?

"This medical study is searching for 30 individuals between the ages 19 and 65 who are experiencing mental depression. Eligible participants must have a QIDS-SR-16 score of 6 or higher, meet DSM-5 criteria for MDD, have a MADRS score in the range 7 to 34 (mild to moderate), be fluent in English, adhere to caffeine consumption protocols, abstain from taking nonprescription medications and supplements one week before drug session day with exceptions as approved by investigators, pass screening tests including ECG and laboratory exams, not experience any changes while on SSRI treatment during trial period; concurrent psychotherapy may allowed if type"

Answered by AI

Who else is applying?

What state do they live in?
British Columbia
Montana
California
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Centre for Neurology Studies x Upstream
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

Need to move beyond this brick wall. In the past I’ve tried Prozac, Wellbutrin, and Effexor. None of which have really helped.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Effect of SSRIs on Response to Psilocybin Therapy
2023. "Effect of SSRIs on Response to Psilocybin Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05594667.
~0 spots leftby Apr 2025
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