Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SMRI Grant ID: 00-093 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A controlled, randomized study on the treatment of schizophrenic psychosis with cannabidiol, a phytocannabinoid is performed. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia. Our group has shown, for example, that Δ9-tetrahydrocannabinol (Δ9-THC) is able to provoke schizophrenia-like psychotic symptoms in healthy volunteers. This, as well as the capability of Δ9-THC to exacerbate productive psychotic symptoms in schizophrenic patients, has recently been confirmed by others. Furthermore, we found that the en-dogenous brain constituent anandamide, an endogenous Δ9-THC agonist, is significantly elevated in the CSF of schizophrenic patients. Cannabinergic substances such as anandamide may enhance dopaminergic neurotrans-mission by increasing dopamine turnover. They may also influence the onset or course of schizophrenia by as yet unidentified mechanisms We seek to investigate the efficacy of cannabidiol in the treatment of schizophrenic and schizophreniform psy-choses, because there is evidence that CB1 antagonists such as SR141716 and cannabidiol have antipsychotic effects comparable to those of classic neuroleptic drugs. Furthermore, cannabidiol is well tolerated showing few side effects in humans. Cannabidiol may serve as an antipsychotic medication that is not primarily based upon an antidopaminergic but upon different mechanisms, especially anticannabinergic ones. It may therefore be an effec-tive medication in at least a subgroup of schizophrenic and schizophreniform patients and may be expected to show additional anxiolytic effects and only minor side effects.
The control condition in this parallel design will be an established neuroleptic treatment with amisulpride that is primarely an antidopaminergic drug. Thus, we will study not only the antipsychotic efficacy of cannabidiol, but we will also compare the effects of both treatment strategies on side effects and neuropsychological functioning.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | Capsules, 3 times daily, 200 mg, 4 weeks |
| |
| Amisulpride |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BPRS total value. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PANSS scores. | 4 weeks | |
| EPS | 4 weeks | |
| Weight gain |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Franz-Markus Leweke, MD | University of Cologne, Dept. of Psychiatry and Psychotherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cologne, Dept. of Psychiatry and Psychotherapy | Cologne | North Rhine-Westphalia | 50924 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33995015 | Derived | Leweke FM, Rohleder C, Gerth CW, Hellmich M, Pukrop R, Koethe D. Cannabidiol and Amisulpride Improve Cognition in Acute Schizophrenia in an Explorative, Double-Blind, Active-Controlled, Randomized Clinical Trial. Front Pharmacol. 2021 Apr 29;12:614811. doi: 10.3389/fphar.2021.614811. eCollection 2021. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D000077582 | Amisulpride |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Capsules, 3 times daily, 200 mg, 4 weeks |
|
| 4 weeks |
| Prolactin levels in serum | 4 weeks |
| D001549 |
| Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |