A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients with Manic Episodes or Manic Episodes with Mixed Features Associated with Bipolar I Disorder (Bipolar Mania)
This research study is looking into a new medication called lumateperone for adults who have bipolar I disorder and are experiencing manic episodes, or manic episodes with mixed features. The main aim is to find out if lumateperone can effectively reduce the symptoms of mania and if it is safe to use. Some participants will receive the new medicine, while others will get a placebo (a tablet with no active ingredient, like a dummy pill). Researchers will compare how both groups feel after three weeks, using special scales to measure changes in their symptoms.
At a glance
What is this study about?
Imagine you or someone you know has bipolar I disorder, and sometimes experiences 'manic episodes'. During these times, people might feel extremely high, have lots of energy, sleep very little, or have racing thoughts. This study, called a Phase III trial, is a big step in testing a new medicine called lumateperone that could potentially help manage these episodes.
The idea behind this study is to see if lumateperone can make a real difference for people struggling with these symptoms. To do this fairly, some people will take the new medicine, while others will take a 'placebo'. A placebo looks exactly like the real medicine but contains no active ingredients. This helps researchers work out if any improvements are genuinely due to the medicine, or if they happen for other reasons, like simply feeling cared for.
Over three weeks, doctors will carefully watch how participants' symptoms change using specific rating scales. They'll also be looking closely at any side effects to make sure the medicine is safe. The results of studies like this are crucial for deciding if a new treatment can become widely available to help people with bipolar disorder.
Key takeaways
- This study is testing a new medicine (lumateperone) for manic episodes in bipolar I disorder.
- It aims to see if the medicine works and if it's safe.
- Some participants will receive the new medicine, others a dummy pill (placebo).
- The main treatment period is three weeks.
- Participation involves regular clinic visits for symptom checks and safety monitoring.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.
Crucially, you must have been diagnosed with Bipolar I Disorder and currently be experiencing a manic episode, or a manic episode with what are called 'mixed features'. Mixed features mean you might have symptoms of both mania and depression at the same time.
The research team will have a detailed list of other requirements, including your current health status and any other medications you are taking, to ensure the study is safe and appropriate for you.
- Are you 18 years old or older?
- Have you been diagnosed with Bipolar I Disorder?
- Are you currently experiencing a manic episode or a manic episode with mixed features?
- Are you comfortable with regular clinic visits and health checks?
- Are you prepared to potentially receive a placebo?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would be involved in this study for approximately three weeks. During this time, you would regularly visit the clinic for check-ups. You would be given either the study medicine (lumateperone) or a placebo, which you would take as instructed. Neither you nor your study doctor would know which one you are receiving – this is called 'double-blind'.
At each visit, the study team would assess your symptoms using specific questionnaires and scales to track how you are feeling. They would also monitor your overall health and look out for any side effects. After the main three-week treatment period, there will be follow-up visits to ensure your safety and monitor your progress.
Potential risks and benefits
Locations (2)
- —Croatia
- —Bulgaria
Common questions
What is a 'manic episode'?
A manic episode is a period of unusually high energy, feeling euphoric, irritable, or having racing thoughts. It's a key part of bipolar I disorder.
What does 'placebo-controlled' mean?
It means some people get the new medicine, and others get a dummy pill (placebo) that looks the same but has no medicine in it. This helps us see if the medicine works better than nothing.
What is 'Bipolar I Disorder'?
It's a mental health condition where people experience significant mood swings, including episodes of mania and sometimes depression.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know. This is called 'blinding' and helps make the study results fair and accurate.
How long will I be in the study?
The main treatment period is about three weeks, with some follow-up visits afterwards.
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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