FLAME (Fluoxetine, Learning and Memory in Epilepsy) Trial
Institute of Psychological Medicine and Clinical Neurosciences, Cardiff University, UK
About the study
Learning and memory problems are common in people with mesial temporal lobe epilepsy (TLE). There are currently no treatments available to improve these. Part of the reason is that we do not really understand what happens in the brains of people with TLE to cause learning and memory problems.
We do know that new brain cells are constantly being formed in a part of the brain called the hippocampus. This is called neurogenesis. The hippocampus is very important for learning and memory and the newly made brain cells are an important part of the learning and memory processes.
We also know that there is less neurogenesis in people with severe TLE. This might explain some of the learning and memory problems they report.
Some research studies have shown that fluoxetine, a widely used medicine, can improve the production of new cells in the hippocampus. Fluoxetine has also been shown to improve learning and memory in animals with TLE.
We now want to find out if fluoxetine can improve learning and memory in a similar way in people with TLE.
When will this study be recruiting?
Now until February 2018
What will participants be asked to do?
If you are interested, we will ask you to attend the University Hospital of Wales (UHW) in Cardiff for an assessment to find out if you are eligible. This will involve:
1. Having a blood test
2. Having an ECG heart check
3. Completing some questionnaires
4. Completing some thinking and learning tasks
5. Having an MRI brain scan
If the assessment shows that you are eligible for the study, we will ask you take part. This will involve:
- Taking a course of tablets for a period of 81 days
- Attending Cardiff University to complete a number of learning and memory tasks, both before and after taking the course of tablets
Who can take part?
You can take part if you:
- Are aged 18-65
- Have a diagnosis of mesial temporal lobe epilepsy
- Are willing and able to travel to Cardiff for testing sessions (we will pay your travel expenses)
- Are able to have an MRI scan
- Are not currently taking anti-depressant medication
Who is conducting the research?
The research is being conducted by a team based at Cardiff University and the University Hospital of Wales (UHW). The chief investigator is Professor William Gray, director of the BRAIN Unit and the professor of neurosurgery at UHW.
Who has reviewed this study?
This study has been reviewed and approved by Cardiff University, Wales NHS Research Ethics Committee 3, the Medicines & Healthcare products Regulatory Agency (MHRA) and the Research & Development Office of the Cardiff and Value University Health Board.