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A Clinical Trial on the Antipsychotic Properties of Cannabidiol

This study has been completed.
Stanley Medical Research Institute
Coordinating Centre for Clinical Trials Cologne
Information provided by:
University of Cologne Identifier:
First received: March 30, 2006
Last updated: July 23, 2008
Last verified: July 2008
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 Intervention Phase
Schizophrenia Psychotic Disorders Drug: Placebo/Cannabidiol Drug: Cannabidiol/Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Cologne:

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

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

Enrollment: 29
Study Start Date: March 2006
Study Completion Date: July 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00309413

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

Responsible Party: F. Markus Leweke, M.D., University of Cologne Identifier: NCT00309413     History of Changes
Other Study ID Numbers: CBD-PT 04-153
Study First Received: March 30, 2006
Last Updated: July 23, 2008

Keywords provided by University of Cologne:
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on August 18, 2017