A Clinical Trial on the Antipsychotic Properties of Cannabidiol
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ClinicalTrials.gov Identifier: NCT00309413 |
Recruitment Status :
Completed
First Posted : March 31, 2006
Last Update Posted : July 25, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia Psychotic Disorders | Drug: Placebo/Cannabidiol Drug: Cannabidiol/Placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Cannabidiol/Placebo
|
Drug: Cannabidiol/Placebo
600 mg/day, oral, capsules, 2 weeks, than cross-over |
Placebo Comparator: 2
Placebo/Cannabidiol
|
Drug: Placebo/Cannabidiol
600 mg/day, oral, capsules, 2 weeks, than cross-over |
- BPRS [ Time Frame: 2 x 2 weeks ]
- PANSS, EPS, Prolactin, ECG etc. [ Time Frame: 2 x 2 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309413
Germany | |
University of Cologne, Dept. of Psychiatry and Psychotherapy | |
Cologne, NRW, Germany, 50924 |
Principal Investigator: | F. Markus Leweke, MD | University of Cologne |
Responsible Party: | F. Markus Leweke, M.D., University of Cologne |
ClinicalTrials.gov Identifier: | NCT00309413 |
Other Study ID Numbers: |
CBD-PT 04-153 |
First Posted: | March 31, 2006 Key Record Dates |
Last Update Posted: | July 25, 2008 |
Last Verified: | July 2008 |
Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Mental Disorders Psychotic Disorders |
Schizophrenia Spectrum and Other Psychotic Disorders Cannabidiol Anticonvulsants |