Active not recruitingPHASE2INTERVENTIONAL

Enhancing Recovery in Early Schizophrenia

This research is looking into a natural substance called cannabidiol, found in cannabis plants but without the 'high' effects, for people with early schizophrenia. Current treatments can have difficult side effects. Previous studies suggest cannabidiol might help with schizophrenia symptoms with fewer side effects than some existing medications. This new study will compare cannabidiol to a dummy pill (placebo) over 12 months, given alongside standard treatments like amisulpride or olanzapine. The aim is to see if cannabidiol is effective and safe for long-term use in helping people manage their schizophrenia symptoms and improve their recovery. Participants will be aged 18-65 and already on stable medication.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Central Institute of Mental Health, Mannheim

Enrolment target

180

Start

08 Apr 2017

Estimated completion

01 Dec 2027

Schizophrenia

What is this study about?

You might be familiar with cannabis, but this study focuses on a specific natural chemical from the plant called cannabidiol (CBD). Unlike other parts of the plant, CBD does not cause the 'high' often associated with cannabis and isn't addictive.

For people living with schizophrenia, current treatments can be helpful but often come with unwanted side effects. Researchers are hopeful that cannabidiol could offer a different way to help manage symptoms. Previous small studies have shown that it might improve symptoms and has a better safety profile, meaning fewer troublesome side effects like weight gain or certain movement problems, compared to some existing medications.

This study wants to learn more about how well cannabidiol works and if it's safe to use over a longer period. It will compare cannabidiol to a 'dummy' pill (placebo) alongside your usual schizophrenia medication for a whole year. This will help doctors understand if cannabidiol can be a valuable addition to current treatments, helping people with early schizophrenia manage their condition more effectively and improve their overall recovery.

Key takeaways

This study explores cannabidiol (CBD) for early schizophrenia.
CBD is natural and doesn't cause a 'high' or addiction.
It aims to reduce symptoms and side effects compared to current treatments.
Participants will take CBD or a dummy pill alongside their existing medication for 12 months.
The study helps doctors understand long-term safety and effectiveness.
Ages 18-65 and on stable medication are generally eligible.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 65 years old. You must have been diagnosed with schizophrenia within the last seven years. You should also be taking a stable dose of one of the commonly used schizophrenia medications, such as amisulpride, aripiprazole, olanzapine, quetiapine, or risperidone, for at least four weeks before starting the study.

There are also a few things that would mean you couldn't join. For example, if you are pregnant or breastfeeding, or if you have certain other serious medical or mental health conditions. If you currently use illegal drugs (other than cannabis or benzodiazepines, which are often prescribed), you would also not be able to participate. The research team will do thorough checks to make sure the study is right for you.

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 65 years old?
Have you been diagnosed with schizophrenia within the last 7 years?
Are you currently taking a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine, or risperidone?
Are you not pregnant or breastfeeding?
Do you not have any other serious medical conditions that would prevent participation?
Have you avoided using illegal drugs (other than for cannabis or certain prescribed medications) recently?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for 12 months. You will receive either the study medication (cannabidiol) or a dummy pill (placebo) in addition to your usual schizophrenia medication. You won't know which one you're getting, nor will your study doctor, which helps ensure unbiased results. You'll have regular visits to the clinic so the research team can monitor your health, check how you're feeling, and assess the effects of the treatment. These visits will likely involve questionnaires, physical checks, and possibly blood tests. Throughout the study, your safety is a top priority, and you'll be closely monitored for any changes or side effects.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You might experience an improvement in your schizophrenia symptoms with potentially fewer side effects compared to current treatments, or you might help advance medical knowledge to benefit others with schizophrenia in the future. However, there are also potential risks; you might experience side effects from the study medication, or the cannabidiol might not work for you. You will be closely monitored for any side effects or worsening of symptoms. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health
Verified postcode
Mannheim, Germany
Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich
Verified postcode
Munich, Germany
Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte
Verified postcode
Berlin, Germany
Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen
Verified postcode
Aachen, Germany
Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne
Verified postcode
Cologne, Germany
Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf
Verified postcode
Hamburg, Germany

Common questions

What is cannabidiol?

Cannabidiol, or CBD, is a natural compound found in cannabis plants. Crucially, it doesn't cause the 'high' that is often associated with cannabis and is not addictive.

Why is this study important?

This study is important because it's looking for new and potentially better ways to treat schizophrenia, especially focusing on reducing side effects that can come with current medications.

Will I stop taking my current medication?

No, you will continue taking your current, stable schizophrenia medication. The cannabidiol or placebo will be given in addition to your usual treatment.

Will I know if I'm getting cannabidiol or a dummy pill?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving cannabidiol or the dummy pill until after the study has finished.

Can I leave the study at any time?

Yes, absolutely. Participating in a clinical trial is always voluntary, and you are free to withdraw from the study at any point, for any reason, and your medical care will not be affected.