Stratification and Treatment in Early Psychosis Study - ENHANCE
The ENHANCE study is testing whether a cannabis-based medicine called cannabidiol (CBD) can help young people (aged 16-40) who are experiencing their first episode of psychosis. These individuals will have already started antipsychotic medication but haven't fully improved or responded well enough. The study aims to see if adding CBD to their existing treatment works better than adding a dummy treatment (placebo). Researchers also want to make sure CBD is safe for people with psychosis. Participants will take either CBD oral solution or a placebo for six weeks. This is a "double-blind" study, meaning neither you nor your doctor will know if you're getting CBD or the dummy pill, which helps ensure fair results.
At a glance
What is this study about?
The ENHANCE study is exploring new ways to help young people who have recently experienced their first episode of psychosis. Psychosis is a mental health condition where someone has trouble telling what's real from what isn't. When someone experiences psychosis for the first time, doctors often prescribe a type of medication called an antipsychotic. However, sometimes these medications don't fully help, or the person doesn't feel much better.
This study is investigating whether adding a specific cannabis-based medicine, called cannabidiol (CBD), to a person's existing antipsychotic treatment can lead to better results. CBD is different from tetrahydrocannabinol (THC), which is the part of cannabis that causes a 'high'. Scientists believe CBD might have properties that could be helpful. The study will compare CBD with a 'placebo' – which looks exactly like the CBD medicine but contains no active ingredients. This helps researchers understand if any improvements are genuinely due to CBD or other factors.
Ultimately, the goal of the ENHANCE study is to find out if CBD can improve treatment for people experiencing their first episode of psychosis and to confirm that it is a safe option. By doing this research, doctors hope to offer more effective treatments in the future for individuals who are still struggling after starting their first antipsychotic medication.
Key takeaways
- New study for people aged 16-40 with a first episode of psychosis.
- Investigating if adding CBD oil helps improve effects of current antipsychotic treatment.
- Compares CBD to a dummy treatment (placebo).
- Study lasts for 6 weeks of treatment.
- Aims to understand if CBD is effective and safe.
- Your participation could help future patients.
Who may be eligible?
To join the ENHANCE study, you would need to be between 16 and 40 years old. You should have been diagnosed with a first episode of psychosis, and currently be taking an antipsychotic medication. Importantly, your doctor should feel that your current medication hasn't fully helped, or that you haven't responded as well as hoped, and that increasing the dose isn't the best option for you.
You also need to be able to understand the study and agree to take part. For women who could become pregnant, it's essential to use effective contraception during and for a period after the study. The study also needs you to be willing to follow all the study instructions and allow your GP or consultant to be informed about your participation.
There are also some reasons why you might not be able to join, though these are typically assessed by the study team. For instance, if you have certain medical conditions or are taking particular medications, or if you can't have an MRI scan (if you choose to have one).
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 16 and 40 years old?
- Have you recently experienced your first episode of psychosis?
- Are you currently taking antipsychotic medication, but feel you haven't fully improved?
- Are you willing and able to follow study instructions and attend appointments?
- If you could become pregnant, are you willing to use effective contraception during the study?
- Are you happy for your GP to be informed about your involvement?
What does participation involve?
If you decide to take part in the ENHANCE study, you would continue your current antipsychotic medication. In addition, you would be given either a CBD oral solution or a matching placebo (a dummy medicine) to take twice a day for six weeks. Neither you nor your study doctor would know which one you are receiving.
Throughout the study, you would have several visits to the clinic where doctors and nurses would check on your health and progress. These visits would include answering questions about how you are feeling and how your symptoms are changing. You might also be asked to provide blood and stool samples. Some participants, at certain study locations, might also be invited to have brain scans (MRIs) to help researchers understand more about psychosis and how treatments work. The total duration of the study medication period is six weeks, with follow-up assessments.
Potential risks and benefits
Locations (17)
- MedUni ViennaVerified postcodeVienna, Austria
- University of AugsburgVerified postcodeAugsburg, Germany
- Charité UniversitätsmedizinVerified postcodeBerlin, Germany
- University Hospital CologneVerified postcodeCologne, Germany
- Ludwig-Maximilian-University MunichVerified postcodeMunich, Germany
- National and Kapodistrian University of AthensVerified postcodeAthens, Greece
- Shalvata Mental Health CenterVerified postcodeHod HaSharon, Israel
- Geha Mental Health CenterVerified postcodePetah Tikva, Israel
- Sheba Medical CentreVerified postcodeRamat Gan, Israel
- University of Campania 'Luigi Vanvitelli'Verified postcodeNaples, Italy
- Stichting Amsterdam UMCVerified postcodeAmsterdam, Netherlands
- Hospital General Universitario Gregorio MarañónVerified postcodeMadrid, Spain
Common questions
What is psychosis?
Psychosis is a mental health condition where a person has difficulty telling what's real from what isn't, which can sometimes involve seeing or hearing things others don't, or having unusual beliefs.
What is CBD?
CBD stands for cannabidiol. It's a natural substance found in the cannabis plant, but it does not cause the 'high' associated with cannabis. Researchers are studying its potential medical uses.
Will I know if I'm taking CBD or a dummy pill?
No, this is a 'double-blind' study. Neither you nor your doctor will know if you're receiving the CBD or the dummy pill (placebo) until after the study is finished. This helps ensure fair and accurate results.
How long will I take the study treatment?
You will take the study treatment (either CBD or placebo) for six weeks, alongside your usual antipsychotic medication.
Do I have to give blood or stool samples?
You would be invited to provide blood and stool samples. These help researchers understand more about the treatment, but you can discuss this with the study team.
How to find out more
Jared Robinson
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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