CYB003 for Depression

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cybin IRL Limited

Must be taking: Antidepressant

Must not be taking: MAOIs, Tricyclics, Antipsychotics, others

Disqualifiers: Schizophrenia, Bipolar, Suicide risk, others

Compensation: Varies

Number of Visits: 16

Duration: 18 weeks

220 Participants Needed

Trial Summary

Trial Summary

This study is for adults with major depressive disorder (MDD) who are still experiencing symptoms even while taking antidepressant medication.

What is the purpose of this trial?

This Phase 3 study is testing whether an investigational drug called CYB003, based on psilocin, may be used as a possible therapeutic in adults with major depressive disorder who continue to experience symptoms despite taking antidepressant medication.

Will I have to stop taking my current medications?

You may not need to stop your current antidepressant medication to join this study. CYB003 is given alongside your existing treatment, and doctors will carefully monitor how the two work together. However, you may need to stop certain medications such as monoamine oxidase inhibitors, tricyclic antidepressants, or antipsychotics after discussing with the study clinic.

How does the drug CYB003 differ from other treatments for depression?

If you qualify for this study, in addition to your regular antidepressant, you will receive two supervised doses of CYB003 combined with psychological support. Traditional medications usually require continuous use over weeks or months.

Eligibility Criteria

This trial is for adults with Major Depressive Disorder (MDD) who have moderate to severe symptoms. They must have a BMI of 40 or less, be on a stable antidepressant for at least 4 weeks prior, and not smoke during the study. Participants need to use contraception and those capable of pregnancy must test negative before dosing. This is not a full list of eligibility criteria.

Inclusion Criteria

Are you currently depressed?

Are you currently on a single medication for your depression that you have taken for at least 4 weeks?

Exclusion Criteria

Do you have an immediate family member (child, sibling, parent) who has been diagnosed with Schizophrenia or Bipolar Disorder or a psychotic disorder?

Do you have a current diagnosis of Post-Traumatic Stress Disorder (PTSD)?

Have you used psychedelics in the past year? e.g. LSD, MDMA, DMT, psilocybin, ayahuasca, mescaline, mushrooms, ecstasy

Timeline

Screening

Participants are screened for eligibility to pariticpate in the trial.

6 weeks

Multiple visits for assessments

Treatment

Participants receive 2 doses of CYB003 16mg or placebo.

6 weeks

2 dosing sessions, approximately 3 weeks apart

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Multiple visits for assessments

Open-label extension (optional)

Non-responders will be eligible to receive CYB003 in a subsequent extension trial

Treatment Details

Interventions

• CYB003

Trial Overview

The trial is evaluating CYB003 for safety and potential efficacy for adults diagnosed with major depressive disorder in addition to their current antidepressant medication.

Participant Groups

Group I: Experimental Arm A: CYB003 in 2 of 2 Dosing Sessions Experimental Treatment 2 Interventions

Arm A participants will receive 16mg 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 during the study.

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

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

Who Is Running the Clinical Trial?

Cybin IRL Limited

Lead Sponsor