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)
This study, called EXTEND, is for people who have major depression and have already taken part in similar studies (APPROACH or EMBRACE) with a new medicine called CYB003. The main aim is to see how long it takes for depression symptoms to return for people who were feeling better after taking CYB003. It also looks at how safe the medicine is over a longer period. Some people might be offered extra doses of CYB003 to see if that helps keep their depression at bay. Essentially, it's about making sure CYB003 can offer lasting relief and checking its effects when used for a longer time.
At a glance
What is this study about?
This study is called EXTEND, and it's designed for people who have been diagnosed with major depressive disorder. Major depression is a serious mental health condition that can cause persistent sadness, loss of interest in activities, and other symptoms that affect daily life. The study is particularly for those who have already participated in earlier studies (named APPROACH or EMBRACE) and have shown improvement in their depression symptoms after taking a new investigational medicine called CYB003.
The main purpose of EXTEND is to understand if CYB003 can help prevent depression symptoms from returning over a long period. Researchers want to find out how long people who have improved with CYB003 can stay well before their symptoms might come back. They will also be carefully monitoring the safety of CYB003 when used for a longer duration. This is a common step in developing new medicines, as it helps doctors understand how a treatment works over time and if it is safe for long-term use.
Another important aspect of this study is to see if giving additional doses of CYB003 can help maintain the improvements in depression. The study will look at different groups of people, including those who responded well in the earlier studies and those who didn't, to understand the full picture of how CYB003 works and if ongoing treatment or booster doses could be helpful.
Key takeaways
- This study is for people with major depression who have already seen improvement with CYB003 in previous trials.
- It aims to understand how long CYB003 can keep depression symptoms from returning.
- The study also checks the long-term safety of CYB003, including if additional doses are helpful.
- Participation involves regular check-ups and receiving the study medicine.
- You must be 18 or older and have taken part in the APPROACH or EMBRACE studies previously.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. A key requirement is that you must have previously participated in one of two specific studies, either the APPROACH study or the EMBRACE study, where you received the experimental medicine CYB003.
Crucially, you should have shown a positive and stable response to the treatment in those earlier studies. This means your depression symptoms would have improved and stayed better for a certain period. The research team will carefully check your medical history to make sure this study is right for you and that taking part is safe.
There might be other health conditions or medications that would prevent you from joining, so the study doctors will go through a full check-up to confirm your suitability.
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.
- Are you 18 years old or older?
- Have you ever taken part in the APPROACH or EMBRACE study for depression?
- Did you receive the CYB003 medicine in one of those studies?
- Did your depression symptoms improve and stay stable during your previous study with CYB003?
What does participation involve?
If you decide to take part in the EXTEND study, you would undergo regular visits with the study team. These visits will involve assessments to check your mood and any depression symptoms you might be experiencing. You would continue to receive the study medicine, CYB003, and for some participants, optional additional doses might be offered.
The study involves regular check-ups with doctors and nurses who will monitor your health and any side effects you might have. You'll likely fill out questionnaires to track your well-being. The total length of your participation in this study would be long-term, as the aim is to see the effects of CYB003 over an extended period. All study-related medication and assessments will be provided at no cost.
Potential risks and benefits
Locations (5)
- —UnverifiedGreece
- —UnverifiedPoland
- —UnverifiedIreland
- —UnverifiedGermany
- —UnverifiedCzechia
Common questions
What is CYB003?
CYB003 is a new medicine being tested to see if it can help people with major depression.
Why is this study called 'EXTEND'?
It's called EXTEND because it's looking at the long-term effects of CYB003, extending what was learned in earlier studies.
Do I have to pay to join the study?
No, all study-related treatments and visits are free of charge.
What if my depression symptoms come back during the study?
The study team will closely monitor you and will discuss options if your symptoms return. Your safety and well-being are their priority.
How long will I be in the study?
The study aims to observe the effects over a long period, so your participation would be for an extended duration. The exact length would be discussed with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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