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A Four-week, Multicentre, Double-blinded, Randomised, Active- and Placebo- Controlled, Parallel-group Trial Investigating Efficacy and Safety of Cannabidiol in Acute, Early-stage Schizophrenic Patients
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Psychiatric Centre Glostrup
Glostrup Municipality, Denmark
Department of General Psychiatry, Heidelberg University
Heidelberg, Baden-Wurttemberg, Germany
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, Germany
Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich
Munich, Bavaria, Germany
Dept. of Psychiatry and Psychotherapy, Technical University Munich
Munich, Bavaria, Germany
Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg
Halle, Saxony-Anhalt, Germany
Start Date
December 8, 2015
Primary Completion Date
September 16, 2024
Completion Date
September 16, 2024
Last Updated
December 27, 2024
150
ESTIMATED participants
Cannabidiol
DRUG
Olanzapine
DRUG
Placebo Cannabidiol
DRUG
Placebo Olanzapine
DRUG
Lead Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
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