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Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)

Join a study to test CYB003's safety for depression treatment.

Recruiting
18-85 years
All
Phase 3

This study is a long-term extension for people who have already participated in two previous trials, called **APPROACH** and **EMBRACE**. It focuses on the safety and long-term effects of a medication named **CYB003** for treating Major Depressive Disorder (**MDD**). To join, you must have completed both doses in the prior trials and continued with the same antidepressant medication. If you can have children, you need to use reliable birth control during and after the study.

Key Points:

  • Participants must have finished the previous trials and received both doses.
  • Females must pass a pregnancy test at the study start and before dosing.
  • The study involves keeping to birth control rules for 12 weeks post-final dose.

People with new symptoms of schizophrenia, significant suicide risk, or heart issues are not eligible. Additionally, those with drug or alcohol issues, or who are sensitive to CYB003, cannot participate. Participants must also agree to be recorded during sessions for research purposes.

Study details
    Major Depressive Disorder

NCT06605105

Cybin IRL Limited

7 March 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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