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

Sponsor:

Collaborators:

Stanley Medical Research Institute

Coordinating Centre for Clinical Trials Cologne

Information provided by:

University of Cologne

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia Psychotic Disorders	Drug: Placebo/Cannabidiol Drug: Cannabidiol/Placebo	Phase 2

Detailed Description:

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 Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Schizophrenia

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

BPRS [ Time Frame: 2 x 2 weeks ]

Secondary Outcome Measures :

PANSS, EPS, Prolactin, ECG etc. [ Time Frame: 2 x 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Germany
University of Cologne, Dept. of Psychiatry and Psychotherapy
Cologne, NRW, Germany, 50924

Sponsors and Collaborators

University of Cologne

Stanley Medical Research Institute

Coordinating Centre for Clinical Trials Cologne

Investigators


Principal Investigator:	F. Markus Leweke, MD	University of Cologne

More Information


Responsible Party:	F. Markus Leweke, M.D., University of Cologne
ClinicalTrials.gov Identifier:	NCT00309413 History of Changes
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

Keywords provided by University of Cologne:


Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:


Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Antipsychotic Agents	Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs

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