Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
This study, called MECT-RESIST, is looking for a better way to help people with a severe mental illness called schizophrenia. Specifically, it focuses on those who haven't gotten better with standard medications, even a strong one called clozapine. For these individuals, electrical treatment to the brain, known as Electroconvulsive Therapy (ECT), has shown promise in the short term. However, people often relapse afterward. This research wants to see if continuing ECT sessions regularly (called maintenance ECT or mECT) after an initial successful course can help prevent these relapses. Researchers will compare mECT plus clozapine to just clozapine alone to see if it leads to fewer relapses, improves daily life, and boosts their overall well-being. The goal is to find effective strategies for those who struggle most with their illness.
At a glance
What is this study about?
Schizophrenia is a serious mental health condition that affects how a person thinks, feels, and behaves. For some people, usual medicines, even a strong one called clozapine, don't help much. This can be very distressing for them and their families. Doctors are constantly looking for better ways to support these individuals.
One treatment that has been around for a while is Electroconvulsive Therapy, or ECT. It involves sending small electrical currents through the brain to trigger a brief seizure. While it might sound scary, it's done very carefully under anaesthetic. ECT has been shown to be effective in the short term for some people with schizophrenia who haven't responded to other treatments. However, the problem is that people can often get unwell again after stopping the ECT.
This study, called MECT-RESIST, wants to find out if continuing ECT regularly (this is called 'maintenance ECT' or mECT) after an initial successful course can help people stay well for longer. The researchers will compare people who receive mECT plus their usual clozapine medicine with those who continue with clozapine alone. They hope to see if mECT can lead to fewer relapses, improve how people manage their daily lives, and boost their overall quality of life. This research is really important because it could lead to new ways of helping people with schizophrenia who are most in need.
Key takeaways
- Targets schizophrenia that hasn't responded to standard medicines, including clozapine.
- Explores if regular, ongoing electrical brain treatment (maintenance ECT) can prevent relapses.
- Compares maintenance ECT plus clozapine to clozapine alone.
- Aims to improve patients' long-term well-being and reduce suffering.
- Could significantly change current guidelines for treating severe schizophrenia.
Who may be eligible?
To be considered for this study, you would need to have schizophrenia. Specifically, your schizophrenia should be resistant to treatment, meaning that clozapine (a type of medication) hasn't worked for you, or you can't take it due to side effects or other medical reasons.
You would also need to be an adult, between 18 and 75 years old.
There are also some reasons why you wouldn't be able to join. For example, if you have severe memory problems (often called dementia), current serious issues with drug or alcohol misuse, certain mood disorders with psychotic symptoms, or some personality disorders, you wouldn't be able to participate. You also couldn't join if you are pregnant or breastfeeding, or if your general health means that ECT treatment would not be safe for you. The study also requires participants to be able to read and write in German.
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.
- Are you between 18 and 75 years old?
- Have you been diagnosed with schizophrenia that hasn't improved with clozapine or you can't take it?
- Do you *not* have severe memory problems or current serious substance misuse issues?
- Are you able to read and write in German?
- Are you *not* pregnant or breastfeeding, and would ECT be safe for your general health?
What does participation involve?
If you join this study, it's divided into two main parts. First, you would receive a standard course of ECT (called 'acute ECT') as part of your regular care, usually over 6 to 9 weeks. If this initial ECT helps you feel significantly better, you would then be randomly assigned to one of two groups for the second part of the study.
One group would continue with your usual clozapine medication. The other group would continue with clozapine *and* receive regular maintenance ECT (mECT) sessions. You would have regular check-ups and assessments to monitor your symptoms, mood, thinking abilities, and overall well-being. The study aims for participants to be in the second part for about 12 months, with follow-up appointments extending beyond that. The full study duration for the last patient could be up to 4 years.
Potential risks and benefits
Locations (14)
- Dept. of Psychiatry, RWTU AachenVerified postcodeAachen, Germany· Not yet recruiting
- Dept. of Psychiatry, University of AugsburgVerified postcodeAugsburg, Germany· Not yet recruiting
- Klinik für Psychiatrie, GöppingenVerified postcodeGöppingen, Germany· Not yet recruiting
- Departmet of Psychiatry, University Medical Center GöttingenVerified postcodeGöttingen, Germany· Not yet recruiting
- Dept. of Psychiatry, Hannover Medical SchoolVerified postcodeHanover, Germany· Not yet recruiting
- Universitätsklinikum Heidelberg, Klinik für Allgemeine PsychiatrieVerified postcodeHeidelberg, Germany· Not yet recruiting
- Zentrum für Psychische GesundheitVerified postcodeIngolstadt, Germany· Not yet recruiting
- Dept. of Psychiatry, University MainzVerified postcodeMainz, Germany· Not yet recruiting
- Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH)Verified postcodeMannheim, Germany· Recruiting
- Dept. of Psychiatry, LMU MünchenVerified postcodeMünchen, Germany· Not yet recruiting
- Clinic for Psychiatry, SaarbrückenVerified postcodeSaarbrücken, Germany· Not yet recruiting
- Klinik für Psychiatrie, SiegenVerified postcodeSiegen, Germany· Not yet recruiting
Common questions
What is 'maintenance ECT'?
Maintenance ECT (mECT) means having regular ECT treatments over a period of time, after an initial course has helped you feel better. It's like a booster to help you stay well.
What does 'treatment-resistant schizophrenia' mean?
This means that your schizophrenia hasn't improved much even after trying different medications, including a strong one called clozapine, which is usually very effective.
Will I know if I'm getting maintenance ECT or just medication?
No, this is a 'blinded' study. This means that you wouldn't know which group you are in, to make sure the results are as fair as possible.
What happens if I feel worse during the study?
Your medical team will closely monitor you throughout the study. If your condition changes or you feel worse, they will adjust your care as needed, and you can always withdraw from the study at any time.
What are the main goals of this study?
The main goals are to see if maintenance ECT can help people with treatment-resistant schizophrenia stay well for longer, have fewer relapses, and improve their general quality of life.
How to find out more
Alexander Sartorius, Prof
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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