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A Clinical Trial on the Antipsychotic Properties of Cannabidiol

This study has been completed.
Sponsor:
Collaborators:
Stanley Medical Research Institute
Coordinating Centre for Clinical Trials Cologne
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00309413
First received: March 30, 2006
Last updated: July 23, 2008
Last verified: July 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • BPRS [ Time Frame: 2 x 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PANSS, EPS, Prolactin, ECG etc. [ Time Frame: 2 x 2 weeks ] [ Designated as safety issue: Yes ]

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 30, 2006
Last Updated: July 23, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013