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Enrolling By InvitationNCT06605105

A Phase III Long-Term Extension study With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in people with Major Depressive Disorder (EXTEND)

This study is enrolling by invitation in the United States and in Australia. It focuses on depression.

DepressionDrugFrom 18 Years to 85 Years
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In plain English

Key information made simple

What is this study testing?

This study is testing whether a study medication may be useful for adults experiencing depression.

What would participation involve?

Participants may receive a study medication, complete questionnaires or follow-up assessments, attend study visits with the research team. The registry lists locations in Australia and in the United States.

Who is it mainly for?

This study appears to be mainly for adults with depression.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

What to expect

Your next step

The official record suggests in-person participation through a clinic, with sites including Combined Research Orlando in Phoenix, Open Mind Collective / UCSF Medical Center - Mount Zion in San Francisco, and Mountain View Clinical Research in Denver. Participation appears to involve using a digital tool or support program and giving feedback through check-ins or assessments. The main fit is usually being able to understand the study and consent and having a stable enough treatment background for the study, while common reasons not to take part include safety concerns that need urgent care first and active substance or alcohol problems that could affect the results. This is a later-stage study, which usually means a larger group and a closer look at how well the approach holds up.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: July 18, 2025
Recruitment status
Enrolling By Invitation
Estimated enrollment
Not clearly listed
Sponsor
Cybin IRL Limited
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Not clearly listed
Locations
United States, Australia
Age range
From 18 Years to 85 Years
Official registry ID
NCT06605105
Official title
A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)
Official source
Official registry link

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Study ID: NCT06605105. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular visits and structured follow-up.

Requires travel, with in-person participation in Australia.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring digital app or tool for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study. The phase is not clearly listed in the public registry. Phase is mostly relevant for medication studies and some device studies. For this study, it may be more useful to look at what is required, the duration, visits, and eligibility criteria.

Do I need to want to stop or reduce tobacco use to participate?

The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Cybin IRL Limited, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The recruitment status is not clearly listed. Check the official registry or contact the study team.

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