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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008245-38 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Cologne | OTHER |
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Despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. Existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the disease. Furthermore, a significant portion of patients is refractory to all current treatments. Therefore new treatment strategies are needed.
Several studies suggest a strong association between schizophrenia and the endocannabinoid system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient - cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one of the most effective modern antipsychotics, amisulpride, but it induced significantly less side effects.
In this phase I safety study, the investigators will evaluate the pharmacokinetics, pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new tablet pharmaceutical preparation of cannabidiol in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Active Comparator | Cannabidiol capsule, 200 mg single dose |
|
| Cannabidiol CR | Experimental | Cannabidiol tablet, various dosages |
|
| Amisulpride and Cannabidiol CR | Experimental | Interaction between Amisulpride and Cannabidiol CR |
|
| Olanzapine and Cannabidiol CR | Experimental | Interaction between Olanzapine and Cannabidiol CR |
|
| Quetiapine and Cannabidiol CR | Experimental | Interaction between Quetiapine and Cannabidiol CR |
|
| Risperidone and Cannabidiol CR | Experimental | Interaction between Risperidone and Cannabidiol CR |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol CR | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of cannabidiol | up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) | up to 10 days | |
| serum antipsychotic concentration | baseline and after seven days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Institute of Mental Health | Mannheim | Baden-Wurttemberg | 68159 | Germany | ||
| Dept. of Pharmacology, University of Cologne |
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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 |
| D000077582 | Amisulpride |
| D000077152 | Olanzapine |
| D000069348 | Quetiapine Fumarate |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| Cannabidiol CR and Placebo | Placebo Comparator | Cannabidiol CR levels without interaction with antipsychotics |
|
|
| Cannabidiol | Drug |
|
| Amisulpride | Drug |
|
| Olanzapine | Drug |
|
| Quetiapine | Drug |
|
| Risperidone | Drug |
|
| Placebo | Drug |
|
| Cologne |
| North Rhine-Westphalia |
| 50931 |
| Germany |
| D001549 |
| Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |