A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
This research study is for individuals aged 18 and older who are experiencing a depressive episode as part of bipolar I or bipolar II disorder. It's a 'Phase 3' study, which means the new medicine, Azetukalner, has already been tested in earlier stages and now needs a larger study to confirm if it's both safe and effective. Participants will be randomly assigned to receive either the new medicine or a dummy treatment (placebo). Neither you nor your study doctor will know which treatment you are receiving. The main aim is to see how much your depression symptoms improve over six weeks, specifically looking at changes in your mood scores. Researchers will also look at other aspects of your mood and daily life to understand the medicine's full effects.
At a glance
What is this study about?
This study is looking into a new medication called Azetukalner for people who have bipolar disorder and are currently experiencing a depressive episode. Bipolar disorder is a condition that affects your mood, often causing extreme highs (mania or hypomania) and lows (depression). This particular study focuses on treating the depressive low periods, which can be very challenging.
The research is what doctors call a 'Phase 3' study. This means Azetukalner has already undergone testing in smaller groups of people and looks promising. Now, a larger study is needed to confirm its effectiveness and safety before it can potentially become more widely available. The study uses a 'double-blind' approach, meaning neither you nor your study doctor will know whether you are receiving Azetukalner or a 'placebo' (a dummy treatment with no active medicine). This helps to ensure the results are as fair and unbiased as possible.
The main goal of this study is to see if Azetukalner can help improve symptoms of depression. Researchers will primarily look at changes in your mood scores over six weeks. They will also track other aspects of your well-being, like your overall condition and how much pleasure you feel, to get a complete picture of whether the new medicine makes a difference.
Key takeaways
- This study is for adults with bipolar depression.
- It's testing a new medicine called Azetukalner against a dummy treatment.
- The main goal is to see if the medicine improves depression symptoms over six weeks.
- Participation involves regular clinic visits, health checks, and mood questionnaires.
- You won't know if you're taking the active medicine or a placebo.
- You can leave the study at any time without affecting your care.
Who may be eligible?
To be able to take part in this study, you need to be at least 18 years old. There's no upper age limit, meaning people of all adult ages are welcome to inquire.
Crucially, you must have been diagnosed with either Bipolar I or Bipolar II disorder, and currently be experiencing a depressive episode. The study is specifically designed for people going through a 'low' period of their bipolar condition.
The study is open to both men and women. If you meet these basic requirements, you might be suitable for further checks to see if the study is right for you.
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?
- Do you have a diagnosis of Bipolar I or Bipolar II disorder?
- Are you currently experiencing a depressive episode?
- Are you willing to attend regular study appointments?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two groups: either you'll receive the new medicine, Azetukalner, or a placebo (a dummy treatment). You won't know which one you're getting, and neither will your study doctor. Typically, you would take the study medicine as prescribed for about 6-8 weeks.
Throughout the study, you would have regular visits to the clinic or study centre. These visits might include talking to a doctor or nurse about how you're feeling, having your general health checked, and completing questionnaires or scales that measure your mood and symptoms. Some visits might involve blood tests.
After the main treatment period, there will be follow-up appointments to check on your health and well-being. The total duration of your involvement, from start to finish, would be explained to you in detail by the study team, but it typically extends beyond the 6-week treatment period to ensure your safety.
Potential risks and benefits
Locations (4)
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What is bipolar depression?
Bipolar depression is the 'low' emotional state experienced by people with bipolar disorder, where they feel very sad, lose interest, and have low energy.
What is a 'placebo'?
A placebo is a dummy pill or treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare the new medicine's effects.
Who is 'double-blind'?
Double-blind means neither you nor your study doctor will know if you're getting the new medicine or the placebo. This keeps the study fair.
How long will the treatment part of the study last?
The main treatment period is usually about six weeks, but your full involvement in the study, including follow-up, might be longer.
Will I still get my usual care?
Participating in the study shouldn't affect your usual medical care. You always have the right to leave the study if you wish.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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