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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | Cannabidiol as add-on to individualized pharmacological treatment |
|
| Placebo | Placebo Comparator | Placebo as add-on to individualized pharmacological treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol as add-on | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause discontinuation | within 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Psychopathology assessed by PANSS | Positive and Negative Syndrome Scale (PANSS) | 6, 9 and 12 month |
| Improvement in Psychopathology assessed by CGI | Clinical Global Impression (CGI) |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects: weight gain | Body Mass Index, abdominal girth | 6, 9 and 12 month |
| Side effects: Vital Signs | heart rate, blood pressure, electrocardiography |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| F. Markus Leweke, MD | Central Institute of Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health | Mannheim | Baden-Wurttemberg | 68159 | Germany | ||
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo as add-on | Drug | 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 |
|
| 6, 9 and 12 month |
| Improvement in Psychopathology assessed by BSI-53 | Brief Symptom Inventory (BSI-53) | 6, 9 and 12 month |
| Improvement in Psychopathology assessed by FROGS | Functional Remission of General Schizophrenia (FROGS) | 6, 9 and 12 month |
| Changes from baseline in Depression Scale | Calgary Depression Scale for Schizophrenia (CDSS) | 6, 9 and 12 month |
| Improvement in social and occupational functioning assessed by GAF | Global Assessment of Functioning (GAF) | 6, 9 and 12 month |
| Improvement in social and occupational functioning assessed by PSP | Personal and Social Performance Scale (PSP) | 6, 9 and 12 month |
| Improvement in social and occupational functioning assessed by EMA | Ecological Momentary Assessment (EMA) | 6, 9 and 12 month |
| Improvement in Quality of life assessed by WHOQUOL-Bref | WHO Quality of Life-Bref (WHOQUOL-Bref) | 6, 9 and 12 month |
| Improvement in Quality of life assessed by LQLP | Lancashire Quality of Life Profile (LQLP) | 6, 9 and 12 month |
| Changes from baseline in Neurocognition assessed by B-CATS | Brief Cognitive Assessment Tool for Schizophrenia (B-CATS) | 6, 9 and 12 month |
| Changes from baseline in Neurocognition assessed by BACS | Brief Assessment of Cognition in Schizophrenia (BACS) | 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) | 6, 9 and 12 month |
| Changes from baseline in Neurocognition assessed by MASC | Movie for the Assessment of Social Cognition (MASC) | 6, 9 and 12 month |
| Changes from baseline in Neurocognition assessed by PFA | Pictures of Facial Affect (PFA) | 6, 9 and 12 month |
| Treatment adherence | 6, 9 and 12 month |
| Changes in Cumulative dose of concomitant or rescue medication | 6, 9 and 12 month |
| Changes of Biomarker: alterations of endocannabinoids and lipdomic profiling | 6, 9 and 12 month |
| 6, 9 and 12 month |
| Side effects: UKU Side Effect rating scale | 6, 9 and 12 month |
| Side effects: Abnormal Involuntary Movement Scale (AIMS) | 6, 9 and 12 month |
| Side effects: Evaluation of extrapyramidal symptoms (EPS) | 6, 9 and 12 month |
| Side effects: physical and neurological examination | 6, 9 and 12 month |
| Standard blood tests | 6, 9 and 12 month |
| Columbia Suicidality Sverity Rating Scale (C-SSRS) | 6, 9 and 12 month |
| Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich |
| Munich |
| Bavaria |
| 80336 |
| Germany |
| Dept. of Psychiatry and Psychotherapy, Charité, Campus Charité-Mitte | Berlin | B | 10117 | Germany |
| Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne | Cologne | North Rhine-Westphalia | 50924 | Germany |
| Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf | Hamburg | 20246 | Germany |