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Psilocybin Analog for Depression (APPROACH Trial)

Phase 3

Recruiting

Research Sponsored by Cybin IRL Limited

Eligibility Criteria Checklist

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

Must have

* Aged 18 to 75 years inclusive, at Screening

* Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 \[if single episode, duration of ≥4 weeks and ≤36 months\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening day-45, baseline day-1, day 2, day 10, day 21, day 23, day 31, and day 42 (end of treatment)

Awards & highlights

Pivotal Trial

Summary

This trial will investigate whether CYB003 is effective, safe, and well-tolerated when used alongside existing treatments for Major Depressive Disorder (MDD).

Who is the study for?

This trial is for adults aged 18-75 with moderate to severe Major Depressive Disorder (MDD) who haven't had enough improvement from their current antidepressants. They must be non-smokers during sessions, have a stable BMI of 40 or less, and if they can have children, agree to use effective contraception.

What is being tested?

The study tests CYB003's effectiveness and safety as an additional treatment for MDD against a placebo. Participants will also receive psychological support. The goal is to see if CYB003 helps improve depression symptoms more than the placebo.

What are the potential side effects?

While specific side effects are not listed here, typical concerns may include changes in mood or perception due to psilocybin analogs like CYB003, along with possible gastrointestinal discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I have been diagnosed with depression that started before I was 60.

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I agree to use effective birth control and have a negative pregnancy test before starting the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening day-45, baseline day-1, day 2, day 10, day 21, day 23, day 31, and day 42 (end of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening day-45, baseline day-1, day 2, day 10, day 21, day 23, day 31, and day 42 (end of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening day-45, baseline day-1, day 2, day 10, day 21, day 23, day 31, and day 42 (end of treatment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary study objectives

The Beck Depression Inventory-Second Edition (BDI-II)

The Clinical Global Impression Scale (CGI-S)

The Generalized Anxiety Disorder 7-item scale (GAD-7)

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental Arm A: CYB003 in 2 of 2 Dosing SessionsExperimental Treatment2 Interventions

Arm A participants will receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm A participants will continue on their current antidepressants and receive psychological support throughout the study.

Group II: Placebo Comparator Arm B: Placebo in 2 of 2 Dosing SessionsPlacebo Group2 Interventions

Arm B participants will receive placebo in 2 of 2 Dosing Sessions, approximately three weeks apart. All Arm B participants will continue on their current antidepressants and receive psychological support throughout the study. Non-responders will be eligible to receive CYB003 in a subsequent extension trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CYB003

2022

Completed Phase 2

~60

Psychological Support

2022

Completed Phase 2

~60