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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
Sponsor:
Collaborators:
Stanley Medical Research Institute
Coordinating Centre for Clinical Trials Cologne
Information provided by:
University of Cologne

Tracking Information
First Submitted Date  ICMJE March 30, 2006
First Posted Date  ICMJE March 31, 2006
Last Update Posted Date July 25, 2008
Study Start Date  ICMJE March 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
BPRS [ Time Frame: 2 x 2 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00309413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2008)
PANSS, EPS, Prolactin, ECG etc. [ Time Frame: 2 x 2 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial on the Antipsychotic Properties of Cannabidiol
Official Title  ICMJE A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Psychotic Disorders
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Cannabidiol/Placebo
    Intervention: Drug: Cannabidiol/Placebo
  • Placebo Comparator: 2
    Placebo/Cannabidiol
    Intervention: Drug: Placebo/Cannabidiol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2008)
29
Original Enrollment  ICMJE
 (submitted: March 30, 2006)
16
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00309413
Other Study ID Numbers  ICMJE CBD-PT 04-153
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party F. Markus Leweke, M.D., University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE
  • Stanley Medical Research Institute
  • Coordinating Centre for Clinical Trials Cologne
Investigators  ICMJE
Principal Investigator: F. Markus Leweke, MD University of Cologne
PRS Account University of Cologne
Verification Date July 2008

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