Clinical Trial to investigate the Effects of Cannabidiol in acute early Schizophrenia (currently enrolling):

A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol as a Treatment for Acutely Ill Schizophrenic Patients

Study code: CBD-FEP


We are currently performing a multi-center clinical trial at the Central Institute of Mental Health and European centers in Denmark, Germany, and Romania with support by the European Commission as part of the OPTiMiSE project.

 

The study investigates the effects of cannabidiol vs. olanzapine or placebo in


acutely psychotic patients suffering schizophrenia with a diagnosis no older than three years at time of inclusion in the study.

 

The study is open for patients fulfilling inclusion criteria and not matching any exclusion criteria in respective countries and from member states of the European Union subject to the ability to speak either fluently English or Danish, German or Romanian.

 

Please check, if you fulfill inclusion criteria and that no exclusion criterium is matched. If this is the case, you may contact us by Email trip@cimh.de if you are willing to participate in the trial. We will then provide further information and may make contact to your nearest study site.

    Inclusion criteria:

  • Informed consent given by the subject

  • DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90 (American Psychiatric Association)

  • Patients must be within the first three years of illness, i.e. first diagnosis of schizophrenia is no older than three years.

  • Age 18 to 65 years, male or female.

  • Acute psychotic symptoms with minimal initial PANSS score of 75 at baseline

  • Female patients of childbearing potential need to utilize a proper method of contraception.

  • Body Mass Index between 18 and 40.

    Exclusion criteria:

  • Lack of accountability (assessed by an independent psychiatrist).

  • History of treatment-resistant schizophrenia, defined as no response to at least two antipsychotics given for a minimum of 6 weeks each in an adequate dosage.

  • Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines).

  • Serious suicidal risk at screening visit (Subject to investigator's and independent psychiatrist's judgement: Poses a serious suicidal or homicidal risk at screening visit or has made a serious suicide attempt within the last 12 months prior to screening visit, or has exhibited homicidal behaviour at anytime during her/his lifetime).

  • Known intolerance or allergy to olanzapine or cannabidiol.

  • Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia.

  • Pregnancy, as determined through a β-HCG pregnancy test, or lactation.


Please note that we are currently not performing clinical trials testing cannabidiol in patients with other diagnosis. A long-term maintenance trial (Study code: CBD-ESPRIT) will be available in Autumn in Germany only.

 

We will update you on our website if new trials will be started.

 

Cannabidiol is a compound in clinical testing and its efficacy and safety in schizophrenia needs to be prooven. Current data do not allow to draw such a conclusion with sufficient certainty. A use of cannabidiol outside of clinical trials is therefore not provided out our center and currently not recommended!

 

We completely understand that many patients are seeking new and less side-effect prone drugs for the treatment of their disorder(s) and don't want to wait that long. However, the process of approval and registration of new compounds has to comply to international rules and competent authorities are thereby able to protect patients towards ineffective or even dangerous drugs in particular in maintenance treatment.

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