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

March 30, 2006
July 23, 2008
March 2006
March 2008   (final data collection date for primary outcome measure)
BPRS [ Time Frame: 2 x 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00309413 on ClinicalTrials.gov Archive Site
PANSS, EPS, Prolactin, ECG etc. [ Time Frame: 2 x 2 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
A Clinical Trial on the Antipsychotic Properties of Cannabidiol
A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Psychotic Disorders
  • Drug: Placebo/Cannabidiol
    600 mg/day, oral, capsules, 2 weeks, than cross-over
  • Drug: Cannabidiol/Placebo
    600 mg/day, oral, capsules, 2 weeks, than cross-over
  • Active Comparator: 1
    Cannabidiol/Placebo
    Intervention: Drug: Cannabidiol/Placebo
  • Placebo Comparator: 2
    Placebo/Cannabidiol
    Intervention: Drug: Placebo/Cannabidiol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
July 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00309413
CBD-PT 04-153
No
F. Markus Leweke, M.D., University of Cologne
University of Cologne
  • Stanley Medical Research Institute
  • Coordinating Centre for Clinical Trials Cologne
Principal Investigator: F. Markus Leweke, MD University of Cologne
University of Cologne
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP