Efficacy and safety of memantine as antimanic and mood-stabilizing medication for adolescents with Bipolar Disorder: a monocentric, randomized, double-blind, placebo-controlled clinical trial.
This research is a trial to investigate a medicine called memantine for young people with bipolar disorder. Bipolar disorder causes big shifts in mood, including periods of feeling overly energetic or irritable (mania). The study aims to find out if memantine can help lessen these manic symptoms and keep moods more stable. Half of the participants will receive memantine, and the other half will get a dummy pill (placebo) – neither they nor their doctors will know who gets what. This helps ensure the results are fair. Researchers will carefully track changes in mood and look for any side effects over 52 weeks.
At a glance
What is this study about?
This study is investigating a new use for a medication called memantine. Memantine is already used for other conditions, but here researchers want to see if it can help teenagers who have bipolar disorder. Bipolar disorder is a condition that causes significant changes in a person's mood, energy, and ability to function. These changes can range from periods of very high energy and excitement (known as mania or hypomania) to periods of deep sadness or low energy.
The main goal of this study is to find out if memantine can effectively reduce the symptoms of mania in young people with bipolar disorder. Researchers will also be looking to see if it helps to keep their moods more stable over time. They will compare memantine to a 'placebo', which is a pill that looks exactly like the study medication but contains no active drug. This comparison is important to know if any improvements are truly due to the memantine or other factors.
The study will follow participants for 52 weeks, carefully observing how they respond to the treatment. They will be checking for improvements in manic symptoms and overall mood stability, as well as keeping a close eye on any side effects that might occur. The information gathered from this study could help doctors better understand and treat bipolar disorder in young people in the future.
Key takeaways
- This study is testing memantine for managing bipolar disorder in young people.
- It aims to reduce manic symptoms and stabilise mood.
- Participants will receive either memantine or a dummy pill (placebo).
- The study lasts for 52 weeks with regular health checks.
- Safety and side effects will be carefully monitored.
- Participation is completely voluntary.
Who may be eligible?
To be part of this study, you need to have a diagnosis of bipolar disorder. The study is open to both boys and girls.
There isn't a specific age limit mentioned, so it's best to discuss with your doctor if they think this study might be suitable for you or your child.
Other specific health conditions or medications might affect whether you can join, but these details are not provided here. Your doctor will be able to check all the detailed requirements.
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.
- Do I have a diagnosis of bipolar disorder?
- Am I open to taking a study medication daily for 52 weeks?
- Am I willing to attend regular appointments for health checks?
- Do I understand that I might receive a dummy pill instead of the active medicine?
What does participation involve?
If you decide to take part in this study, you will be given either the study medicine, memantine, or a dummy pill (placebo) for 52 weeks. Neither you nor your doctor will know which one you are taking until the end of the study. You will take the tablets each day as instructed.
You will have regular visits with the study team. During these visits, they will chat with you about how you're feeling, ask about your mood symptoms, and check your overall health and any side effects. This involves answering questions and possibly having some simple health checks. The study team will keep track of how your manic symptoms change over the 52 weeks. If your symptoms don't improve enough, your doctor might decide to add another medication called aripiprazole to your treatment. The total duration of active participation in the study is 52 weeks.
Potential risks and benefits
Locations (1)
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Common questions
What is bipolar disorder?
Bipolar disorder is a health condition that causes big shifts in a person's mood, energy, and ability to do everyday tasks. People can have periods of feeling very high and energetic (mania) and periods of feeling very low and sad.
What is memantine?
Memantine is a medication that is being studied to see if it can help young people with bipolar disorder by reducing manic symptoms and helping to keep moods more stable. It's already approved for other conditions.
What is a placebo?
A placebo is a pill that looks exactly like the study medicine but doesn't contain any active drug. It's used in studies to fairly compare the new medicine's effects against not taking the active medicine.
How long does the study last?
The study lasts for 52 weeks, which is about one year. During this time, you will take the study medication or placebo and have regular check-ups.
Can I stop participating in the study if I want to?
Yes, you have the right to leave the study at any time, for any reason, without it affecting your regular medical care.
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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