Current antipsychotic treatments of schizophrenia 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 and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Cannabidiol capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks
Placebo capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks
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, Charité, Campus Charité-Mitte
Berlin, B, Germany
Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany
Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf
Hamburg, Germany
All-cause discontinuation
Time frame: within 12 month
Improvement in Psychopathology assessed by PANSS
Positive and Negative Syndrome Scale (PANSS)
Time frame: 6, 9 and 12 month
Improvement in Psychopathology assessed by CGI
Clinical Global Impression (CGI)
Time frame: 6, 9 and 12 month
Improvement in Psychopathology assessed by BSI-53
Brief Symptom Inventory (BSI-53)
Time frame: 6, 9 and 12 month
Improvement in Psychopathology assessed by FROGS
Functional Remission of General Schizophrenia (FROGS)
Time frame: 6, 9 and 12 month
Changes from baseline in Depression Scale
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: 6, 9 and 12 month
Improvement in social and occupational functioning assessed by GAF
Global Assessment of Functioning (GAF)
Time frame: 6, 9 and 12 month
Improvement in social and occupational functioning assessed by PSP
Personal and Social Performance Scale (PSP)
Time frame: 6, 9 and 12 month
Improvement in social and occupational functioning assessed by EMA
Ecological Momentary Assessment (EMA)
Time frame: 6, 9 and 12 month
Improvement in Quality of life assessed by WHOQUOL-Bref
WHO Quality of Life-Bref (WHOQUOL-Bref)
Time frame: 6, 9 and 12 month
Improvement in Quality of life assessed by LQLP
Lancashire Quality of Life Profile (LQLP)
Time frame: 6, 9 and 12 month
Changes from baseline in Neurocognition assessed by B-CATS
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Time frame: 6, 9 and 12 month
Changes from baseline in Neurocognition assessed by BACS
Brief Assessment of Cognition in Schizophrenia (BACS)
Time frame: 6, 9 and 12 month
Changes from baseline in Neurocognition assessed by UPSA-B
University of California San Diego Performance based Skills Assessment (UPSA-B)
Time frame: 6, 9 and 12 month
Changes from baseline in Neurocognition assessed by MASC
Movie for the Assessment of Social Cognition (MASC)
Time frame: 6, 9 and 12 month
Changes from baseline in Neurocognition assessed by PFA
Pictures of Facial Affect (PFA)
Time frame: 6, 9 and 12 month
Treatment adherence
Time frame: 6, 9 and 12 month
Changes in Cumulative dose of concomitant or rescue medication
Time frame: 6, 9 and 12 month
Changes of Biomarker: alterations of endocannabinoids and lipdomic profiling
Time frame: 6, 9 and 12 month
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