A Clinical Trial on the Antipsychotic Properties of Cannabidiol

Study Overview
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Brief Summary
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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.

Detailed Description
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Despite recent advances in the treatment of schizophrenia and schizophreniform disorders, there is still a need to develop efficient and better tolerated psychopharmacological approaches to this group of diseases. The endogenous cannabinoid system provides a promising target in the pharmacotherapy of these disorders. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia and that cannabidiol is effective in treating acute psychotic symptoms of schizophrenic patients. We will investigate cannabidiol versus placebo in a randomized, double blind design with extensive safety measures. The primary hypothesis to be tested is that Cannabidiol is expected to be superior to placebo in the treatment of acute schizophrenic and schizophreniform psychoses with regard to its antipsychotic efficacy.

Official Title
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A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol

Conditions
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Schizophrenia, Psychotic Disorders

Intervention / Treatment
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* Drug: Placebo/Cannabidiol
* Drug: Cannabidiol/Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV Diagnosis of schizophrenic or schizophreniform psychosis Minimal initial score of 36 in the BPRS total score and a minimum of 12 in the BPRS Psychosis Cluster, including items 4 (conceptional disorganisation), 8 (exaggerated self-esteem), 12 (hallucinatory behaviour), and 15 (unusual thought content) Exclusion of pregnancy in female subjects through negative β-HCG test Exclusion Criteria: Lack of accountability Pregnancy or risk of pregnancy or lactation. Other relevant interferences of axis 1 according to diagnostic evaluation through MINI including undifferentiated residual forms of schizophrenia. Treatment with depot-antipsychotics during the last three months. Severe internal or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures. Positive Hepatitis-serology. QTc-elongation. Acute suicidal tendency of or hazard to others by the patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Cannabidiol/Placebo | Drug: Cannabidiol/Placebo<br>* 600 mg/day, oral, capsules, 2 weeks, than cross-over<br>|
| Placebo Comparator: 2<br>Placebo/Cannabidiol | Drug: Placebo/Cannabidiol<br>* 600 mg/day, oral, capsules, 2 weeks, than cross-over<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BPRS |  | 2 x 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS, EPS, Prolactin, ECG etc. |  | 2 x 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia and Disorders with Psychotic Features