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

Summary

Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's population. Current antipsychotics are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9-tetrahydrocannabinol. While cannabidiol has no psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute paranoid schizophrenics the investigators showed a significant clinical improvement in all symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol displayed a significantly superior side-effect profile. This study is to evaluate the efficacy and safety of this novel treatment option in comparison to placebo and olanzapine, an established second generation antipsychotic in the treatment of acute schizophrenia and schizophrenia maintenance therapy, in a four-week clinical trial.

Conditions

• Schizophrenia

Interventions

DRUG

Cannabidiol

Cannabidiol capsules

DRUG

Olanzapine

Olanzapine capsules

DRUG

Placebo Cannabidiol

Placebo cannabidiol capsules

DRUG

Placebo Olanzapine

Placebo olanzapine capsules

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Glostrup University Hospital, Copenhagen

  collaborator OTHER

• Central Institute of Mental Health, Mannheim

  lead OTHER

Principal Investigators

• F. Markus Leweke, MD · Central Institute of Mental Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-08

Primary Completion

2024-09-16

Completion

2024-09-16

Countries

• Denmark
• Germany

Study Locations