A Double-Blind, Oral, Placebo-Controlled, Multiple-Dose, Parallel, Randomized Study to Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
This research study is looking into a new medicine called Endoxifen for adults with Bipolar I Disorder. Bipolar I Disorder is a condition where people experience extreme mood swings, including periods of high energy and activity (mania) and sometimes periods of low mood (depression). The study aims to find out if Endoxifen can help reduce the symptoms of mania and if it is safe for people to take. Participants will either receive Endoxifen or a dummy pill (placebo) that looks exactly the same, so neither they nor their doctors will know which one they are taking. This helps ensure fair results. The main goal is to see how much symptoms improve over 21 days.
At a glance
What is this study about?
This study, called a Phase III trial, is a crucial step in testing a new medicine named Endoxifen for people living with Bipolar I Disorder. Bipolar I Disorder is a mental health condition that causes significant shifts in mood, energy levels, and activity, ranging from very high and energetic periods (mania) to sometimes very low and sad periods (depression).
The main purpose of this research is to see if Endoxifen can effectively reduce the symptoms of mania and if it is safe for people to use. Participants in the study will be given either the actual Endoxifen medicine or a 'placebo.' A placebo is a dummy pill that looks, tastes, and feels exactly like the real medicine but contains no active drug. This is done so that neither the patient nor the doctors know who is getting the real medicine. This 'double-blind' approach helps to ensure the study results are as accurate and unbiased as possible, showing whether Endoxifen itself is making a difference.
Over a period of 21 days, the researchers will carefully monitor how participants' symptoms change. They will use standard tests to measure improvements in manic symptoms and will also look at other aspects of the participants' health and well-being, including how they feel emotionally and if their condition is improving overall. They will also check for any side effects and see if the participants need other medicines for agitation during the study.
Key takeaways
- This study is testing a new medicine called Endoxifen for Bipolar I Disorder.
- It aims to see if Endoxifen helps with manic symptoms and is safe.
- Participants will receive either Endoxifen or a look-alike dummy pill (placebo).
- The main treatment period for the study is 21 days.
- You would need to be 18 or older to potentially join.
- Both men and women can participate in this research.
Who may be eligible?
To join this study, you would need to be an adult, at least 18 years old. There is no upper age limit mentioned, meaning older adults could also be considered.
Both men and women are welcome to take part in this research.
The study is specifically for people who have been diagnosed with Bipolar I Disorder. This means your doctor would need to confirm you have this specific type of bipolar condition before you could join.
- Are you 18 years old or older?
- Have you been diagnosed with Bipolar I Disorder?
- Are you able to take medication by mouth?
- Are you willing to attend regular study visits for 21 days and complete assessments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will be given either the study medicine, Endoxifen, or a dummy pill (placebo) to take by mouth. The pills will look identical, so you won't know which one you are receiving – and neither will your study doctor. This is standard practice in medical research to get the clearest results.
The main part of the study will last for 21 days. During this time, you'll have regular visits with the study team. These visits will involve assessments to check your symptoms, such as how you're feeling and your mood, using standard questionnaires like the YMRS and MADRS. The team will also monitor your overall health, ask about any side effects you might be experiencing, and possibly take blood samples to check the levels of the study medicine in your body.
They will record if you need any other medications for agitation or if you withdraw from the study for any reason. The total duration of your participation, including any follow-up after the 21 days, would be explained in full detail by the study team.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is Bipolar I Disorder?
Bipolar I Disorder is a mental health condition involving significant mood swings, including episodes of high energy and excitement (mania) and sometimes periods of depression.
What is Endoxifen?
Endoxifen is the new medicine being tested in this study. Researchers want to see if it can help improve symptoms of mania in people with Bipolar I Disorder.
What is a 'placebo'?
A placebo is a 'dummy pill' that looks exactly like the actual medicine but contains no active drug. It helps researchers understand if the real medicine is genuinely having an effect.
How long will the study last?
The main treatment part of the study will last for 21 days, during which your symptoms and health will be closely monitored.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctor will know if you are receiving Endoxifen or the placebo. This is called a 'double-blind' study and helps ensure fair results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.