A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)
This research study, called BUOY-1, is looking into a new medication called SPT-300 (also known as GlyphAllo) for adults who have major depression, and some who also experience anxiety. The main goals are to find out if this new medication is safe to use and how well it works to reduce depression and anxiety symptoms. Participants will be randomly put into two groups: one group will receive the new medication, and the other will receive a placebo (a dummy pill with no active medicine). This helps researchers fairly compare how well GlyphAllo works. Everyone involved, including the study team and the participants, won't know who is getting the real medication until the study is over. This is a common way to conduct fair and accurate research to find new treatments.
At a glance
What is this study about?
This study is a clinical trial looking into a potential new treatment for major depression, a serious mood disorder that can affect how you feel, think, and handle daily activities. Many people with major depression also experience anxiety, and this study includes individuals with both conditions. The new medication being tested is called SPT-300, or GlyphAllo.
The main aim of this study is to see if SPT-300 is both safe to use and effective at helping to improve symptoms of depression and anxiety. This research is in 'Phase 2', which means it's an important step where scientists gather more information about how the medication works in people, including the right dose and any side effects. Finding new and better treatments for depression is very important, as current options don't work for everyone, and some people experience difficult side effects.
To make sure the results are fair and accurate, this study is designed in a specific way. It's 'randomised', meaning participants are put into groups by chance. It's 'double-blind', which means neither you nor the study team will know if you're receiving SPT-300 or a 'placebo' (a dummy pill that looks like the real medication but contains no active drug). This helps prevent any bias when measuring how well the treatment works. Everyone in the study will also receive only the study medication; they won't be taking other depression medications at the same time to clearly see the effects of SPT-300.
Key takeaways
- This study is testing a new medication, GlyphAllo, for depression with or without anxiety.
- It's a Phase 2 study, meaning it's exploring safety and effectiveness in people.
- Participants will be randomly assigned to receive either GlyphAllo or a dummy pill (placebo).
- Neither you nor the study team will know which treatment you are getting.
- You will have regular check-ups and assessments to monitor your progress and safety.
- You can withdraw from the study at any time without affecting your medical care.
Who may be eligible?
This study is looking for men and women aged between 18 and 65 years old who have been diagnosed with major depression. You need to have had depression for at least four weeks but no more than 18 months.
While the main focus is depression, you might also be able to join if you have certain anxiety conditions (like generalised anxiety, social anxiety, or panic disorder), as long as your doctor agrees that your depression is your main health concern. It's important that your body mass index (BMI) is between 18 and 40. For women who could become pregnant, you must agree to use effective birth control during the study and for 30 days after your last dose, and you shouldn't be breastfeeding.
However, you can't join if you have or have had certain other mental health conditions, such as depression with psychosis, bipolar disorder, schizophrenia, or severe obsessive-compulsive disorder. Also, if you've been in hospital for depression recently, or if two or more previous treatments for your current depression episode haven't worked, you wouldn't be able to take part. You also need to be willing to avoid using recreational drugs during the study.
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 between 18 and 65 years old?
- Have you been diagnosed with major depression?
- Has your current depressive episode lasted at least 4 weeks but no more than 18 months?
- Do you have a healthy body mass index (BMI between 18 and 40)?
- Are you willing and able to avoid recreational drug use during the study?
- Are you able to use effective birth control if you are a woman who could become pregnant?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance to either receive the new medication (SPT-300) or a placebo (a dummy pill). You and the study team won't know which one you're taking. You'll need to visit the study clinic regularly for check-ups, assessments of your mood and symptoms, and to receive your study medication. These visits will involve discussions about how you're feeling and could include questionnaires or other simple tests to monitor your progress. The total duration of your participation in the study will involve regular contact with the study team, typically over several weeks or months, including a follow-up after your last dose of medication.
Potential risks and benefits
Locations (59)
- Seaport Investigator SiteVerified postcodeChino, United States· Recruiting
- Seaport Investigator SiteVerified postcodeGarden Grove, United States· Recruiting
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- Seaport Investigator SiteVerified postcodeLauderhill, United States· Recruiting
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- Seaport Investigator SiteVerified postcodeWest Palm Beach, United States· Recruiting
- Seaport Investigator SiteVerified postcodeAtlanta, United States· Recruiting
- Seaport Investigator SiteVerified postcodeDecatur, United States· Recruiting
Common questions
What is 'Major Depressive Disorder'?
Major Depressive Disorder (MDD) is a serious mood condition that causes ongoing feelings of sadness, loss of interest, and can affect your daily life and energy levels.
What does 'Anxious Distress' mean in this study?
Anxious distress means experiencing noticeable anxiety symptoms alongside your depression, such as feeling tense, restless, or worrying a lot.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the real medication but contains no active ingredients. It's used to fairly compare the new medication's effects.
Will I know if I'm getting the real drug or the placebo?
No, this is a 'double-blind' study, meaning neither you nor the study team will know what you are receiving until the study is finished. This helps ensure fair results.
Can I take my usual depression medication during the study?
No, in this study, you would only be taking the study medication (SPT-300 or placebo), not other antidepressant medicines. This helps researchers clearly see the effects of the new drug.
How to find out more
Clinical trial information desk
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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