Using cannabidiol to improve recovery in early schizophrenia

Enhancing Recovery in Early Schizophrenia - a Multi-center, Two-arm, Double-blind, Randomized Phase II Trial Investigating Cannabidiol Vs. Placebo As an Add-on to an Individualized Antipsychotic Treatment

This study is testing if adding cannabidiol to standard treatments can help people with early schizophrenia recover better and have fewer side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Central Institute of Mental Health, Mannheim (Academic / other)
• Locations: 6 sites (Mannheim, BW and 5 other locations)
• Trial ID: NCT02926859 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of cannabidiol as an add-on treatment for patients with early-stage schizophrenia who are already receiving standard antipsychotic medications. The study aims to determine whether cannabidiol can enhance recovery while minimizing side effects compared to a placebo. Participants will be monitored for clinical improvements and any adverse effects over the course of the trial. The research is based on previous findings that suggest cannabidiol may offer a favorable side-effect profile compared to traditional antipsychotics.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with schizophrenia within the last seven years who are stable on certain antipsychotic medications.

Not a fit: Patients with serious suicidal risk or those with a history of substance abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for managing schizophrenia symptoms.

How similar studies have performed: Previous studies have shown promising results with cannabidiol in treating schizophrenia, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Informed consent given by the subject
* DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90)
* First documented diagnosis of schizophrenia must not be no older than seven years.
* Patients must receive a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine or risperidone (TAU: treatment as usual) at least 4 weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.
* Initial PANSS total score of ≤ 75 at baseline.
* proper contraception in female patients of childbearing potential
* body mass index between 18 and 40.

Exclusion Criteria:

* Lack of accountability
* positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
* serious suicidal risk at screening visit
* other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
* other relevant neurological or other medical disorders
* pregnancy or lactation.

Where this trial is running

Mannheim, BW and 5 other locations

• Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health — Mannheim, Bw, Germany (Recruiting)
• Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich — Munich, By, Germany (Not_yet_recruiting)
• Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte — Berlin, B, Germany (Recruiting)
• Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen — Aachen, Nrw, Germany (Recruiting)
• Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne — Cologne, Nrw, Germany (Recruiting)
• Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf — Hamburg, Germany (Recruiting)

Study contacts

• Principal investigator: F. Markus Leweke, MD — Central Institute of Mental Health
• Study coordinator: F. Markus Leweke, MD

Conditions Schizophrenia