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 at a new medicine called lumateperone for adults (aged 18 and over) who have Bipolar I Disorder and are currently having a manic episode (sometimes called 'bipolar mania'). A manic episode can involve feeling overly excited, restless, or having racing thoughts. The study is designed to see how well lumateperone works compared to a 'dummy pill' (a placebo) and to check its safety. Participants will be randomly given either the new medicine or the placebo. Researchers will closely monitor changes in symptoms over three weeks to understand if lumateperone can effectively help manage these episodes. This is a crucial step in developing new treatments for bipolar disorder.
At a glance
What is this study about?
This study is a research project focusing on Bipolar I Disorder, specifically when someone is experiencing a manic episode. A manic episode means feeling unusually energetic, restless, or having big changes in mood and behavior. Sometimes, these episodes can also have 'mixed features,' meaning they include some symptoms of depression at the same time. The main goal is to test a new medicine called lumateperone.
Researchers want to find out if lumateperone can help reduce the symptoms of a manic episode and how safe it is to use. To do this, some people will receive the new medicine, while others will receive a 'placebo.' A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps scientists understand if any improvements are due to the medicine itself or other factors. This type of study is a 'Phase III' trial, which means it's one of the final steps before a new medicine might become widely available.
The study's main way of checking if the medicine works is by observing changes in a special score that measures manic symptoms over three weeks. They will also look at other scores that measure overall illness severity. This information is vital for understanding if lumateperone could become a helpful new treatment option for people living with bipolar disorder.
Key takeaways
- This study is testing a new medicine (lumateperone) for adults with Bipolar I Disorder during a manic episode.
- It aims to see if the medicine reduces symptoms and is safe, compared to a dummy pill (placebo).
- You must be 18 or older and currently experiencing a manic episode to be considered.
- Participation involves taking daily medicine/placebo for three weeks and attending regular clinic visits.
- Your decision to join is voluntary, and you can withdraw at any time.
- The study helps develop new treatments for bipolar disorder.
Who may be eligible?
To join this study, you need to be an adult, meaning 18 years old or older. The study is open to everyone, regardless of whether you are male or female.
The most important requirement is that you must have been diagnosed with Bipolar I Disorder and currently be experiencing a manic episode. This could also include manic episodes that have some depressive symptoms mixed in. Your doctor will be able to confirm if your current symptoms fit the study's requirements.
While the information provided is brief, there will be other specific health requirements for taking part that a study doctor will discuss with you. These are put in place to ensure your safety and that the study results are clear.
- Am I 18 years old or older?
- Have I been diagnosed with Bipolar I Disorder?
- Am I currently experiencing a manic episode or a manic episode with mixed features?
- Am I able to attend regular clinic appointments for about three weeks?
- Am I comfortable potentially receiving a placebo (dummy pill)?
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 in this study, you'll be involved for a period of several weeks. Initially, you'll have a screening visit to make sure you meet all the study's requirements. If you qualify, you'll be 'randomised,' which means you'll be randomly assigned to either receive the new medicine (lumateperone) or a placebo (a dummy pill that looks the same).
You'll take the study medicine or placebo daily for three weeks. During this time, you'll have regular visits to the study clinic. These visits will involve discussions with doctors and nurses about your symptoms and how you're feeling. They will use special questionnaires to track any changes in your manic symptoms.
You'll also have regular health checks, which might include blood tests, checking your vital signs (like blood pressure), and perhaps other medical assessments. After the three-week treatment period, there will be a follow-up visit to make sure you're well and to collect any final information. The exact number of visits and tests will be explained in detail by the study team.
Potential risks and benefits
Locations (2)
- —Bulgaria
- —Romania
Common questions
What is Bipolar I Disorder?
Bipolar I Disorder is a mental health condition that causes extreme mood swings that include emotional highs (mania or hypomania) and lows (depression). This study focuses on manic episodes.
What is a 'manic episode'?
A manic episode involves a period of abnormally elevated, expansive, or irritable mood and increased energy or activity, lasting at least one week. It can include symptoms like racing thoughts, decreased need for sleep, and impulsive behaviour.
What is a 'placebo'?
A placebo is a 'dummy pill' that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers understand if the new medicine works better than no treatment.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor the study doctors will know whether you are receiving the active medicine or the placebo. This helps make the study results fair and unbiased.
How long will I be in the study?
The main part of the study involves taking medicine for three weeks, with some visits before and after this period. The full duration of your participation will be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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