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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Cannabidiol capsules
Olanzapine capsules
Placebo cannabidiol capsules
Placebo olanzapine capsules
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
Change in the Positive and Negative Syndrome Scale (PANSS) total score
Time frame: within 4 weeks
Changes in the PANSS subscores and clusters
Time frame: within 4 weeks
Changes in the Clinical Global Impression score
Time frame: within 4 weeks
Changes in the Global Assessment of Functioning Scale
Time frame: within 4 weeks
Changes in the Personal and Social Performance Scale
Time frame: within 4 weeks
Changes in the Calgary Depression Scale for Schizophrenia
Time frame: within 4 weeks
Changes in the Hamilton Anxiety Scale
Time frame: within 4 weeks
Changes in cognitive skills
Time frame: within 4 weeks
Response to antipsychotic medication
Time frame: within 4 weeks
Plasma levels of endogenous cannabinoids
Time frame: within 4 weeks
Changes in physiological parameter
Time frame: within 4 weeks
Changes in the UKU Side Effect Rating Scale
Time frame: within 4 weeks
Columbia Suicidality Severity Rating Scale
Time frame: within 4 weeks
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