University of Cologne [provisional name] (Cannabidiol for schizophrenia [provisional name])
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A Clinical Trial on the Antipsychotic Properties of Cannabidiol

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Registry of Trials clinicaltrials.gov
Year 2006
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The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study.

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Cannabidiol as a new type of an antipsychotic: results from a placebo-controlled clinical trial

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Conference 49th Annual Conference of the American College of Neuropsychopharmacology. Published in: Neuropsychopharmacology. 2010;35(suppl 1):S280
Year 2010
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Background: There is urgent need for the identification of new pharmacological targets for the treatment of schizophrenia. We recently discovered that increase of anandamide levels by blocking its degradation by administration of cannabidiol, a purified phytocannabinoid, is accompanied by significant improvement of symptoms in acute schizophrenic patients. Methods: We performed a randomized, double-blind, placebocontrolled, cross-over clinical trial in acute, antipsychotic-naive, first-break paranoid schizophrenia patients, fulfilling diagnostic criteria of DSM-IV. 29 patients were treated after written informed consent with either cannabidiol (600 mg per day) or placebo for 14 days and than switched to the corresponding cross-over condition. Additional patients to gain a total of 18 patients treated per protocol replaced dropouts. Results: Cannabidiol significantly improved psychotic symptoms in the cannabidiol-placebo condition during the first 14 days of treatment when compared to baseline. A MMRM analysis of all randomized patients (n=29) yielded an mean improvement of 2.4 points (standard error 3.0) on PANSS total in favor of cannabidiol (vs. placebo), albeit not statistically significant. Only one patient on sequence cannabidiolplacebo terminated treatment early (last seen at visit 3) whereas 10 patients terminated early on sequence placebo-cannabidiol. The most frequent reason given was worsening of symptoms (5/11 patients). Discussion: Although limited by design issues (cross-over), duration of treatment (14 days), and relevant placebo-response rates, this is the second study to provide evidence for antipsychotic properties of cannabidiol accompanied by a superior side-effect profile. Future placebo-controlled parallel-group trials studying the antipsychotic properties of cannabidiol in acute schizophrenia are necessary to provide further evidence for its efficacy in the treatment of this devastating disease.

Primary study

Unclassified

Cannabidiol as a new type of an antipsychotic: results from a placebo-controlled clinical trial

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Conference 67th Annual Scientific Convention and Meeting of the Society of Biological Psychiatry
Year 2012
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Biol Psychiatry. 2012;78(8)(suppl 1):63S

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The endocannabinoid system as a pharmacological target for antipsychotic treatment and more?

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Conference 8th International Conference on Early Psychosis: From Neurobiology to Public Policy
Year 2012
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Early Interv Psychiatry. 2012;6(suppl 1):7

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The Endocannabinoid System in Schizophrenia - a Mechanistically New Approach to its Pathophysiology and Treatment

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Authors Leweke M
Conference International Congress on Schizophrenia Research, Florida, USA (S341). Published in: Schizophrenia Bulletin. 2013;39(1):341
Year 2013
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BACKGROUND: There is urgent need for an improved understanding of pathomechanisms of schizophrenia to enable improved new pharmacological treatments. We initially identified one of the two major endocannabinoids, anandamide, as a counterbalancing if not protective factor in paranoid schizophrenia. Most recently, we reported that increasing levels of anandamide by blocking its metabolization by cannabidiol (CBD) significantly ameliorates psychotic symptoms in acute schizophrenia (Leweke et al., Transl Psychiatry 2012). Here, we report on the results of the first clinical trial comparing CBD vs. placebo in acutely exacerbated, first-break paranoid schizophrenia patients. METHODS: We performed a randomized, double-blind, placebo-controlled, cross-over clinical trial in acute, antipsychotic- naive, first-break paranoid schizophrenia patients, fulfilling diagnostic criteria of DSM-IV. 29 patients were treated after written informed consent with either CBD or placebo for 14 days and than switched to the corresponding cross-over condition. Additional patients to gain a total of 18 patients treated per protocol replaced dropouts. Serum was taken at baseline and on days 14 and 28. In addition, 14 patients provided cerebrospinal fluid (CSF) at baseline and day 28 for biomarker investigations. RESULTS: CBD significantly improved psychotic symptoms in the CBDplacebo condition during the first 14 days of treatment when compared to baseline. A MMRM analysis of all randomized patients (n = 29) yielded a mean improvement of 2.4 points (standard error 3.0) on PAN SS total in favor of CBD (vs. placebo), albeit not statistically significant. Only one patient on sequence CBD-placebo terminated treatment early (last seen at visit 3) whereas 10 patients terminated early on sequence placebo- CBD. The most frequent reason given was worsening of symptoms (5/11 patients). In addition, CBD was detectable in serum of almost all patients in the CBD-placebo group. Side-effects of CBD were on the level of placebo. CONCLUSION: Although limited by design issues, duration of treatment, carry-over effects, and relevant placebo-response rates, this is the second study to provide evidence for antipsychotic properties of CBD accompanied by a superior side-effect profile. Future placebo-controlled parallel-group trials studying the antipsychotic properties of CBD in acute schizophrenia are necessary to provide further evidence for its efficacy in the treatment of this devastating disease.

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Enhancing recovery in early schizophrenia–a controlled clinical trial investigating cannabidiol Cr vs. placebo as an add-on to antipsychotic treatment

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Conference 9th International Conference on Early Psychosis (Published in: Early Intervention in Psychiatry)
Year 2014
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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 signifi cant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a signifi cantly superior side-effect profi le in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profi le and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and effi cacy data is still lacking. This study in 180 remitted schizophrenia patients is to evaluate the effi - cacy 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 olanzapine or amisulpride, 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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MODULATION OF THE ENDOCANNABINOID SYSTEM AS A POTENTIAL NEW TARGET IN THE TREATMENT OF SCHIZOPHRENIA

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Conference 4th Biennial Schizophrenia International Research Conference (Published in: Schizophrenia Research)
Year 2014
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BACKGROUND: New pharmacological targets for the treatment of schizophrenia are urgently required. We initially identified one of the two major endocannabinoids, anandamide, as a counterbalancing if not protective factor in paranoid schizophrenia. Most recently, we reported that increasing levels of anandamide by blocking its metabolization by cannabidiol, a purified phytocannabinoid, significantly ameliorates psychotic symptoms in acute schizophrenia. METHODS: We performed a randomized, double-blind, placebo-controlled, cross-over clinical trial in acute, antipsychotic-naive, first-break paranoid schizophrenia patients, fulfilling diagnostic criteria of DSM-IV. 29 patients were treated after written informed consent with either cannabidiol (600 mg per day) or placebo for 14 days and than switched to the corresponding cross-over condition. Additional patients to gain a total of 18 patients treated per protocol replaced dropouts. RESULTS: Cannabidiol significantly improved psychotic symptoms in the cannabidiol-placebo condition during the first 14 days of treatment when compared to baseline. A MMRM analysis of all randomized patients (n=29) yielded a mean improvement of 2.4 points (standard error 3.0) on PANSS total in favor of cannabidiol (vs. placebo), albeit not statistically significant. Only one patient on sequence cannabidiol-placebo terminated treatment early (last seen at visit 3) whereas 10 patients terminated early on sequence placebo- cannabidiol. The most frequent reason given was worsening of symptoms (5/11 patients). In addition, cannabidiol was detectable in serum of almost all patients in the cannabidiol-placebo group. Side-effects of cannabidiol were on the level of placebo. CONCLUSION: Although limited by design issues (cross-over), duration of treatment (14 days), carry-over effects (serum levels of cannabidiol), and relevant placebo-response rates, this is the second study to provide evidence for antipsychotic properties of cannabidiol accompanied by a superior side-effect profile. Future placebo-controlled parallel-group trials studying the antipsychotic properties of cannabidiol in acute schizophrenia are necessary to provide further evidence for its efficacy in the treatment of this devastating disease.