Schizophrenia is a complex psychiatric condition characterized by a plethora of symptoms that affects the way a person thinks, acts, expresses emotions, perceives reality, and relates to others.

A clinical trial is a study that investigates a treatment for medical conditions, including schizophrenia. People volunteer to participate in these studies, which can include investigating potential new medicines, surgeries, or other treatments.

Before a trial can begin, it must be carefully planned, reviewed, and approved.

The different phases of a clinical trial are designed to test a new treatment in a step-by- step process:

Phase I - Phase I tests a small group of healthy volunteers to see how safe a new treatment is and what the right dose should be.

Phase II - Phase II tests whether the treatment is effective and safe in a larger group of people with a specific disease.

Phase III - Phase III tests the treatment on even more people with a specific disease in different parts of the world. This is usually the last step before approval (marketing authorization).

Phase IV - Phase IV studies take place after a treatment has been approved and are designed to gather more information about the treatment over a longer period of time.

Some common misconceptions about clinical trials include the belief that participants are used as "guinea pigs", that participation leads to a loss of control over personal health information, or that clinical trials are only for people who are terminally ill. In reality, clinical trials follow strict ethical guidelines and regulations to protect participants.

Clinical trials are conducted within esteemed medical facilities, including hospitals and research institutes. For comprehensive details regarding the ongoing clinical trial CBD- ESPRIT, we encourage you to refer to our designated page, which provides comprehensive and up-to-date information about this specific clinical trial.

Double-blind means that neither the participants nor the researchers administering the treatment will know who is receiving the active treatment or a placebo, an identical looking drug that does not contain the pharmacologically active compound.

The purpose of the clinical trial CBD-ESPRIT is to see if cannabidiol can help with schizophrenia treatment when added to other antipsychotic medications. We will look at how safe and effective it is, whether it helps prevent relapses, and if people stick to taking it regularly.

The additional study goals focus on understanding how cannabidiol affects mental health, daily functioning, thinking abilities, and motor skills. This includes investigating its impact on motor function, often affected by unwanted side effects of antipsychotic medication. The study also looks into its influence on prolactin levels*, weight, and the total amount of rescue medication required.

To date, the active ingredient cannabidiol has not yet been approved for the treatment of schizophrenia. In 2019, EPIDYOLEX (active ingredient: cannabidiol) was approved by the European Commission as an add-on therapy for rare forms of epilepsy in children (Lennox- Gastaut syndrome or Dravet syndrome). Cannabidiol has already been evaluated in a clinical trial for its efficacy in acute schizophrenia compared to the antipsychotic amisulpride. Both treatments were found to be safe and resulted in significant improvement in symptoms, but fewer side effects occurred with cannabidiol treatment. For more information about this clinical trial, visit www.ClinicalTrials.gov with identifier: NCT00628290.

To date, the active ingredient cannabidiol has not yet been approved for the treatment of schizophrenia.

Currently available antipsychotics offer a useful approach in the treatment of schizophrenia, but at least 30% of patients do not respond to this treatment or discontinue therapy due to intolerable side effects.

Therefore, alternatives with fewer side effects, such as CBD, are being researched. Cannabidiol does not lead to neurological symptoms or weight gain. The CBD-ESPRIT study is investigating whether CBD can be considered as a standard treatment for schizophrenia.

Please inform the site staff of any complaints, illnesses or injuries that occur during the clinical trial. If you think they are serious, please report them immediately, by telephone if necessary. We will give you a telephone number to call if you need to speak to your study doctor at any time during the trial. It is important that you follow your investigator's instructions exactly.

CBD is generally well-tolerated but can still cause side effects. As everyone is different, everyone may react differently to CBD. In particular, the following side effects have been observed, but may not occur in everyone: Somnolence, fatigue, dizziness, headache, dry mouth, nausea and diarrhoea, and skin rashes. Any changes in your symptoms or side effects should be reported to the study team.

CBD (cannabidiol) and THC (delta-9- tetrahydrocannabinol) are two main natural components of the cannabis plant that have different effects. Unlike THC, CBD does not induce so-called altered states of consciousness or psychotic symptoms and has no known addictive potential.

Cannabidiol is an active ingredient that is still in clinical trials. This means that its efficacy and safety in the treatment of schizophrenia have not yet been proven. The current data do not allow us to draw conclusions with sufficient certainty.

The use of cannabidiol outside of clinical trials is therefore not offered in the participating clinics and is currently not recommended!

To participate in this study, you must meet the criteria for early schizophrenic psychosis (including disorganised (295.10), catatonic (295.20), paranoid (295.30), or undifferentiated (295.90) schizophrenia according to the DSM- IV-TR classification).

If you receive CBD in addition to your standard therapy, your condition may be relieved. However, since efficacy has not been proven, you may not get the benefit you are hoping for by participating in this clinical trial. Furthermore, if you receive placebo capsules instead of CBD, you will not receive any additional benefit from participating. However, your participation, with or without personal benefit, may contribute to a better understanding of the disease. The results of the study may also help improve the treatment of schizophrenia in the future. Advances in medical care, thanks to clinical trial volunteers, enhance health for millions. Therefore, your voluntary participation in clinical trials may improve the long-term health of millions of people through advances in medical care.

The Federal Institute for Drugs and Medical Devices (BfArM) is a government agency responsible for the approval and regulation of drugs and medical devices in Germany. In recent years, the BfArM has approved the use of cannabidiol in various clinical trials conducted by Prof. Dr. Markus Leweke, including the CBD-ESPRIT trial.

The CBD-ESPRIT study has been reviewed and given a positive assessment by the responsible ethics committee. It has also been approved by the Federal Institute for Drugs and Medical Devices (BfArM).

First, your study doctor at the participating clinic (trial site) will explain the clinical trial in detail and answer any questions you may have. You will also receive a detailed explanation of what your participation in the study will entail. Participation in the clinical trial involves regular visits to the clinic, during which your physical and mental well-being will be assessed using questionnaires and physical examinations. During some visits, neuropsychological tests, an ECG, and blood samples will also be taken. For more information, please visit https://www.cbd-esprit.de/study-overview.

The preliminary examinations can only be performed if you have given your written informed consent to participate in the clinical trial.

This is a multi-center, two-arm, parallel-group, double-blind, randomized, placebo-controlled phase II clinical trial. You can find more information about this at https://www.cbd-esprit.de/study-overview.

This clinical trial CBD-ESPRIT is only aimed at people diagnosed with schizophrenia. People with other mental illnesses (e.g., schizoaffective disorder, depression, anxiety disorder or bipolar disorder) cannot participate in view of the study objective.

The availability of medical institutes or psychiatric departments suitable for conducting a clinical trial may vary across different cities. It may also be the case that facilities that are suitable in principle may already be operating at full capacity, which means that they cannot take part in this particular clinical trial.

You can view the list of trial sites participating in the CBD-ESPRIT clinical trial at https://www.cbd-esprit.de/participarting-centers-1. If you use the contact form on the website to express your interest in the clinical trial, you have the option to select the trial site that is closest and most accessible to you.

For further information about a particular trial site, we recommend reaching out to us through the contact form available at https://www.cbd-esprit.de/contact-us. Once we have received your enquiry, we will forward it to the appropriate trial site, and they will contact you as soon as possible.

If you do not have a diagnosis, you will need to be thoroughly assessed and diagnosed by the study doctors at the trial site. As this clinical trial is investigating cannabidiol as an add-on treatment to current standards of care for schizophrenia, a stable oral therapy with amisulpride (up to 1200 mg/day), aripiprazole (up to 30 mg/day), olanzapine (up to 20 mg/day), paliperidone (up to 12 mg/day), quetiapine (up to 750 mg/day) or risperidone (up to 10 mg/day) is a prerequisite. To ensure that the maximum effect of the medication is achieved before the start of the trial, it must be taken regularly for at least 2 weeks prior to enrolment in the trial. Participation in the trial must be stopped if standard therapy is discontinued during the trial. This means that if you are not already taking any medication, you must be willing to start taking it at least 2 weeks before the start of the trial and continue to take it for the entire duration of the trial.

To express your interest in the CBD-ESPRIT clinical trial, please use the form provided for this purpose. Please select the form and complete the required fields. We will review your information for eligibility and forward your request to the appropriate study site, which will contact you as soon as possible.

Before we can enroll you in the CBD-ESPRIT clinical trial, we need to make sure that you meet all of the study's inclusion criteria and that you do not meet any of the exclusion criteria. Some criteria (e.g., age, body mass index) are easy to verify, while others require extensive testing (e.g., blood tests). If you have decided to participate in the study and have given your written consent after a detailed informed consent discussion, the preliminary examination (screening, V0) can begin, which may take up to 10 days. At the end of the screening, it will be determined whether you meet all the inclusion criteria for the clinical trial and whether there are any exclusion criteria. The number of days between the screening and final enrollment may vary because your availability and that of the physicians must be coordinated so that your study doctor can spend sufficient time with you during the first and subsequent visits.

The clinical trial lasts over a period of one year. It is structured into three distinct phases: an initial six-month period encompassing the treatment phase involving either CBD or the placebo medication, followed by a tapering-off period. Subsequently, a six-month follow-up phase consists of three scheduled visits.

Of course you can. You can withdraw from the clinical trial at any point, even after it has started. You do not have to give a reason. Discontinuation will not affect your treatment and you will not suffer any disadvantages. In this case, you can simply continue your standard treatment. Inform your study doctor to ensure a safe transition to your standard treatment.

Your decision to terminate your participation in the CBD-ESPRIT trial early will not affect your treatment or your relationship with your treating physician. Your health and wellbeing are our top priority, and we respect your decisions. Your study doctor will discuss with you how and where you will continue your treatment.

Pseudonymization of data is an important protection mechanism used in research and healthcare to preserve the privacy and anonymity of study participants. Your clinical trial related data will also be stored in encrypted (pseudonymized) form. This means that no information is used that directly identifies you (e.g., name, contact details, date of birth, etc.), but only a number and letter code. Your investigator will create a pseudonymized list of your contact information, which will be stored at the study site and protected from unauthorized access. This is necessary in order to be able to reassign this personal data to you if necessary. Such decryption will only take place to the extent permitted by law, particularly in cases where it is necessary to contact you for security reasons. However, it can never be completely ruled out that even without this list, conclusions can be drawn about your person.

Your personal data will be kept strictly confidential and stored in a pseudonymized form. This means your name will be replaced by an identification number. Only a few people will have access to your personal information or the pseudonymization list. All documents collected as part of the clinical trial bear only your pseudonymization code.

No, you will not be paid for your participation in the CBD-ESPRIT clinical trial. You will also be treated as an outpatient during the clinical trials, as the study is conducted in addition to your standard of care. Therefore, we can only reimburse you for travel expenses in exceptional cases.

Just as you can withdraw your consent to participate in the clinical trial, you can also withdraw your consent to the processing of the collected data at any time. Data that is no longer re- quired will be deleted immediately, unless there are legal and/or official documentation and reporting obligations to the contrary. However, the data processing that took place until the withdrawal remains lawful.

No. As this is a randomized, double-blind trial, you will not be able to choose which treatment you receive. Randomized double-blind means, first, that participants are randomly assigned to one of the two groups (CBD or placebo) and that neither the participants nor the researchers conducting the clinical trial know who is receiving the active treatment or placebo.

In principle, it is possible to perform all examinations not only in German but also in English, provided that your study doctor and the study team are comfortable in communicating in English with you. However, you must be fluent in German or English.

The clinical trial CBD-ESPRIT only takes place in Germany, in the following cities: [insert names of participating cities].

No, there is no limit.

If a family member is participating in a clinical trial, it is important to respond in an empathetic and supportive way. Respect your family member's privacy and personal choices and avoid pressuring them. Educate yourself about the study to gain a better understanding of its purpose and process. Offer your support, whether it is emotional support or practical help. Find an exchange with other family members or friends to share your feelings and concerns if needed. Remember that medical research is of utmost importance to gain new knowledge and develop therapies that can benefit many people. Ultimately, it is crucial to respond to your family member's decision with respect, understanding and empathy and to support them during the study process.

Placebo is a treatment with no expected therapeutic benefit but looks identical to the study drug containing the active ingredient. It is substance that is used as a control in clinical trials testing new drugs.