We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

A Clinical Trial on the Antipsychotic Properties of Cannabidiol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00309413
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : July 25, 2008
Stanley Medical Research Institute
Coordinating Centre for Clinical Trials Cologne
Information provided by:
University of Cologne

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.

Layout table for study information
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
Drug: Cannabidiol/Placebo
600 mg/day, oral, capsules, 2 weeks, than cross-over

Placebo Comparator: 2
Drug: Placebo/Cannabidiol
600 mg/day, oral, capsules, 2 weeks, than cross-over

Primary Outcome Measures :
  1. BPRS [ Time Frame: 2 x 2 weeks ]

Secondary Outcome Measures :
  1. PANSS, EPS, Prolactin, ECG etc. [ Time Frame: 2 x 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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

Layout table for location information
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
Layout table for investigator information
Principal Investigator: F. Markus Leweke, MD University of Cologne
Layout table for additonal information
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
Keywords provided by University of Cologne:
Schizophrenia and Disorders with Psychotic Features
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders