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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004335-23 | EudraCT Number |
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Following the expiry of the original research grant, no follow-up financing could be provided to complete the study.
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| Name | Class |
|---|---|
| Martin-Luther-Universität Halle-Wittenberg | OTHER |
| Heidelberg University | OTHER |
| Technical University of Munich | OTHER |
| Ludwig-Maximilians - University of Munich |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | Cannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks |
|
| Olanzapine | Active Comparator | Olanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks |
|
| Placebo | Placebo Comparator | Placebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | Cannabidiol capsules |
| |
| Olanzapine |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Positive and Negative Syndrome Scale (PANSS) total score | within 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the PANSS subscores and clusters | within 4 weeks | |
| Changes in the Clinical Global Impression score | within 4 weeks | |
| Changes in the Global Assessment of Functioning Scale |
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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 |
|---|---|---|---|---|---|---|
| Psychiatric Centre Glostrup | Glostrup Municipality | 2600 | Denmark | |||
| Department of General Psychiatry, Heidelberg University |
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| OTHER |
| Glostrup University Hospital, Copenhagen | OTHER |
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| Drug |
Olanzapine capsules |
|
|
| Placebo Cannabidiol | Drug | Placebo cannabidiol capsules |
|
| Placebo Olanzapine | Drug | Placebo olanzapine capsules |
|
| within 4 weeks |
| Changes in the Personal and Social Performance Scale | within 4 weeks |
| Changes in the Calgary Depression Scale for Schizophrenia | within 4 weeks |
| Changes in the Hamilton Anxiety Scale | within 4 weeks |
| Changes in cognitive skills | within 4 weeks |
| Response to antipsychotic medication | within 4 weeks |
| Plasma levels of endogenous cannabinoids | within 4 weeks |
| Changes in physiological parameter | within 4 weeks |
| Changes in the UKU Side Effect Rating Scale | within 4 weeks |
| Columbia Suicidality Severity Rating Scale | within 4 weeks |
| Heidelberg |
| Baden-Wurttemberg |
| 68115 |
| Germany |
| Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health | Mannheim | Baden-Wurttemberg | 68159 | Germany |
| Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich | Munich | Bavaria | 80336 | Germany |
| Dept. of Psychiatry and Psychotherapy, Technical University Munich | Munich | Bavaria | 81675 | Germany |
| Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg | Halle | Saxony-Anhalt | 06112 | Germany |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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