A Phase 2/3, Multicenter, Randomized, Double blind, Placebo controlled Trial of the Safety and Efficacy of Flexible Doses of SEP 363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder.
This research study is looking at a new medication, SEP-363856, for adults who are dealing with major depression and are already receiving treatment with other antidepressants. The main goal is to find out if adding SEP-363856 to their current medication helps improve their depression symptoms more effectively. Researchers will also be checking to make sure the new medicine is safe and doesn't cause too many side effects. This is a large study that compares the new medicine to a dummy pill (placebo) to get a clear picture of its effects. It's a key step in seeing if this new treatment could help people feel better.
At a glance
What is this study about?
This study is a clinical trial that aims to find better ways to help adults living with major depression. Depression can be a very challenging condition, and sometimes, even with standard antidepressant medication, people still struggle with symptoms. This trial is investigating a new medicine called SEP-363856, to see if adding it to an existing antidepressant treatment can make a significant difference. It's important to develop new treatments so that more people can find relief and improve their quality of life.
The study is designed to be very thorough. Some participants will receive the new medicine, SEP-363856, while others will receive a placebo (a dummy pill that looks like the new medicine but contains no active ingredients). This is so researchers can accurately compare the effects of the new medicine against no additional active treatment. Neither the patient nor their doctor will know who is getting which, which helps keep the results unbiased. The main thing the researchers will be looking at is how much depression symptoms change over time for people taking the new medicine compared to those taking the placebo.
This kind of research is vital for advancing medical care. If SEP-363856 proves to be both safe and effective, it could become a new option for people who haven't fully responded to their current antidepressant treatment. The information gathered from trials like this helps doctors understand which treatments work best for different individuals, ultimately leading to improved care for mental health conditions.
Key takeaways
- This study is testing a new 'add-on' medicine for major depression.
- It's for adults currently taking antidepressants who still have symptoms.
- Participants will receive either the new medicine or a dummy pill.
- The study lasts about 14 weeks with regular check-ups.
- Safety and effectiveness are the main things being measured.
Who may be eligible?
This study is looking for adult volunteers, aged 18 or older, who have been diagnosed with major depression. You would need to be currently taking an antidepressant medication and still experiencing symptoms, as the study is testing if the new medicine can be an 'add-on' treatment to your existing therapy.
Both men and women are welcome to participate. The study will carefully review your full medical history and current health to make sure it's safe for you to take part and that the results of the study will be clear and helpful.
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 been diagnosed with major depression?
- Are you currently taking an antidepressant medication?
- Are you still experiencing symptoms of depression despite your current treatment?
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to see if you meet all the requirements. If you do, you would then be randomly assigned to either receive the new study medicine (SEP-363856) or a placebo (a dummy pill). You and your study doctor would not know which one you are receiving.
Your participation would involve regular visits to the clinic over a period of about 14 weeks. During these visits, the study team would monitor your health closely. This includes checking your depression symptoms, taking blood samples, monitoring your heart (with an ECG), checking your vital signs like blood pressure and heart rate, and discussing any side effects you might experience. You would continue to take your regular antidepressant medication throughout the study. After the main treatment period, there would likely be some follow-up appointments to check on your well-being.
Potential risks and benefits
Locations (6)
- —UnverifiedCzechia
- —UnverifiedBulgaria
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedHungary
- —UnverifiedGermany
Common questions
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers understand if the new medicine is truly effective compared to no active treatment.
Will I know if I'm getting the new medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving the new medicine or the placebo. This is called 'double-blind' and helps keep the study unbiased.
How long will I be in the study?
The main part of the study where you take the medicine and have regular check-ups will last about 14 weeks. There might be some follow-up appointments after that.
Can I continue taking my current antidepressants?
Yes, you must continue taking your current antidepressant medication as this study is testing the new medicine as an 'add-on' treatment.
What if I change my mind about participating?
You are free to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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