Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
This research study, called EXTEND, is a follow-up for people who have already taken part in two previous studies named APPROACH or EMBRACE. In those studies, participants received a new medicine called CYB003 for major depression. The main goal of EXTEND is to see how safe CYB003 is when used for a longer period, and if it continues to help with depression symptoms over time. It's an important step to understand if CYB003 could be a useful new treatment option. Participants must have finished the previous trial and received all their doses to be considered for this extension study.
At a glance
What is this study about?
This study is called EXTEND, and it's a very important follow-up for people who have already taken part in two previous research studies for depression, known as APPROACH or EMBRACE. In those earlier studies, participants received a new medication called CYB003. The EXTEND study is designed to gather more information about this medicine over a longer period.
The main purpose is to carefully check two key things: first, how safe CYB003 is when people take it for an extended time, and second, how well it continues to work to help manage the symptoms of major depression. Understanding both the safety and effectiveness over a longer period is crucial for doctors and researchers to decide if this new medicine could be a good treatment option in the future.
By joining this study, you would be helping researchers learn more about depression and potential new ways to treat it. This information helps improve care for many people living with depression. This study is only for those who have already completed the initial phases of the CYB003 research program.
Key takeaways
- This study is a follow-up for people already in CYB003 depression trials.
- It checks the long-term safety and how well CYB003 works for depression.
- Only participants of the previous APPROACH or EMBRACE studies are eligible.
- You must be 18-85 years old to take part.
- Contraception rules apply for those who can have children.
- Close medical monitoring will be provided throughout the study.
Who may be eligible?
To join this study, you must have successfully completed one of the previous studies (APPROACH or EMBRACE) and received all the doses of the study medicine, CYB003. You also need to have been taking the same antidepressant medication at a steady dose throughout that earlier study.
It's important that you are willing to give your written permission to take part and follow all the study's rules. If you are a man who can produce sperm, or a woman who can become pregnant, there are specific rules about using contraception to prevent pregnancy during and after the study period. You must be between 18 and 85 years old.
You cannot join if you developed new symptoms of conditions like schizophrenia or other serious mental health problems during the previous study, or if you are at a high risk of suicide. Also, if you have certain heart problems or other serious medical issues, you may not be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Did I complete the APPROACH or EMBRACE study for CYB003?
- Did I receive all the study medicine in that previous trial?
- Am I between 18 and 85 years old?
- Am I willing to use contraception if needed and follow study rules?
- Do I currently have any new symptoms of serious mental health conditions like schizophrenia?
- Do I have a high risk of suicide or certain heart conditions?
What does participation involve?
As this is an extension study, your participation will involve continuing to be monitored for your health and the effects of CYB003. While the specific details aren't fully outlined here, typically this means you will have regular visits to the clinic or hospital. These visits might include blood tests, physical examinations, and questionnaires to assess your mood and how you're feeling. You'll continue to take the study medication, CYB003, as directed.
The study will continue to check for any side effects and how well the treatment is working for your depression over a longer period. There will also be specific instructions for contraception if you are able to have children. The total duration of your participation will be explained fully by the study team.
Potential risks and benefits
Locations (49)
- Scottsdale Research InstituteVerified postcodePhoenix, United States
- Behavioral Research Specialists, LLCVerified postcodeGlendale, United States
- Kadima Neuropsychiatry InstituteVerified postcodeLa Jolla, United States
- TRIP Clinic and Psychedelic Science InstituteVerified postcodeLos Angeles, United States
- CalNeuro Research GroupVerified postcodeLos Angeles, United States
- Lipov Medical GroupVerified postcodeLos Angeles, United States
- Excell Research, IncVerified postcodeOceanside, United States
- Open Mind Collective / UCSF Medical Center - Mount ZionVerified postcodeSan Francisco, United States
- Inland Psychiatric Medical Group Inc (IPMG Research)Verified postcodeSan Juan Capistrano, United States
- Mountain View Clinical ResearchVerified postcodeDenver, United States
- Starlight Clinical ResearchVerified postcodeEvergreen, United States
- Research Centers of AmericaVerified postcodeHollywood, United States
Common questions
What is CYB003?
CYB003 is a new medicine being studied to see if it can help treat major depression. It's not yet available to the public.
Who can join this study?
This study is only for people aged 18 to 85 who have already completed the previous APPROACH or EMBRACE studies for depression and received CYB003.
What will I have to do in the study?
You will continue to take the study medicine and attend regular check-ups where your health will be monitored, and your depression symptoms assessed.
Are there any risks to taking part?
Like any medicine, CYB003 might have side effects. The study team will monitor you closely, and you can stop participating at any time.
Why is this study important?
This study helps researchers understand the long-term safety and effectiveness of CYB003, which is vital for developing new depression treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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