OSU6162 as add-on in SSRI/SNRI-resistant depression (ODEN): a double-blind, placebo-controlled evaluation of efficacy and safety
This research study, called ODEN, is investigating a new medication called OSU6162. It's designed for individuals living with depression who haven't found enough relief from common antidepressant medications like SSRIs or SNRIs. The main goal is to find out if OSU6162, given as an add-on treatment, can effectively reduce the symptoms of depression. We also want to understand if it's safe to use. To do this, some participants will receive OSU6162, while others will receive a placebo (a pill with no active medicine). This helps us fairly compare the new treatment. The study is in an early stage (Phase II), meaning it's still exploring how well the treatment works.
At a glance
What is this study about?
This study, known as ODEN, is for people who are experiencing depression that hasn't gotten better with standard antidepressant medications. These standard medications often include types called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors). If you've tried these and are still struggling, this study is looking into a new treatment called OSU6162.
The main idea behind this research is to see if adding OSU6162 to your current treatment can help reduce your depression symptoms. We'll be comparing it to a 'placebo', which looks exactly like the study medicine but doesn't contain any active drug. This comparison is really important to know for sure if any improvements are genuinely due to OSU6162 or other factors.
This is a Phase II study, which means it's an important step where we explore how well a new treatment might work and check for any side effects. The information gathered will help doctors understand if OSU6162 could be a helpful option for people with depression that is challenging to treat.
Key takeaways
- Study for depression not improving with standard treatments.
- Compares new drug OSU6162 with a dummy pill (placebo).
- Aims to check if OSU6162 helps reduce depression symptoms and is safe.
- Open to adults aged 18 and over, both men and women.
- Your health will be closely monitored throughout the study.
Who may be eligible?
This study is looking for adults who are at least 18 years old. There's no upper age limit, so older adults are welcome to participate too. Both men and women can join this study.
The most important thing is that you have a diagnosis of depression, and you've found that your current antidepressant medications (like SSRIs or SNRIs) haven't fully helped your symptoms. The study specifically wants to include people whose depression hasn't responded well to these common treatments.
There might be other specific health conditions or medications that would prevent you from taking part, but the main criteria are being an adult with depression that's been difficult to treat with standard antidepressants.
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 depression?
- Are your current antidepressant medications (like SSRIs or SNRIs) not working well enough for you?
- Are you comfortable with the idea of potentially receiving a placebo?
- Are you able to attend regular study appointments?
What does participation involve?
If you decide to take part in this study, you'll be assigned to one of two groups: either receiving the new investigational medication OSU6162 or receiving a placebo (a dummy pill). You won't know which one you're getting, and neither will the study team, to keep things fair. You'll take the assigned medication as an add-on to your current depression treatment.
Your involvement will include several visits to the study clinic. During these visits, the study team will carefully check your health, ask you questions about your depression symptoms, and you might have some simple tests like blood pressure checks. They'll use a specific tool to measure your depression symptoms to see how they change over time. The total duration of your participation in the study, including all treatments and follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is OSU6162?
OSU6162 is an investigational medication being studied to see if it can help people with depression that hasn't responded well to other treatments.
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the study medication but contains no active ingredients. It helps us compare the new medicine fairly.
Will I know if I'm getting the active drug or the placebo?
No, in this study, neither you nor the doctors will know who is receiving the active drug and who is receiving the placebo. This is called 'double-blind'.
What if I feel worse during the study?
Your safety and well-being are the top priority. The study team will monitor you closely, and you should always report any changes in how you feel immediately. You can withdraw from the study at any time.
How long will the study last?
The study team will explain the exact duration of your participation, including how long you'll take the treatment and any follow-up appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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