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Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis (CBD-CT1)

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ClinicalTrials.gov Identifier: NCT00628290
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : March 18, 2008
Sponsor:
Information provided by:
University of Cologne

Tracking Information
First Submitted Date  ICMJE February 26, 2008
First Posted Date  ICMJE March 5, 2008
Last Update Posted Date March 18, 2008
Study Start Date  ICMJE October 2002
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
Change in BPRS total value. [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00628290 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
  • Change in PANSS scores. [ Time Frame: 4 weeks ]
  • EPS [ Time Frame: 4 weeks ]
  • Weight gain [ Time Frame: 4 weeks ]
  • Prolactin levels in serum [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis
Official Title  ICMJE Evaluation of the Antipsychotic Efficacy of the Phytocannabinoid Cannabidiol in Treating Acute Schizophrenic Psychosis. A Double-Blind, Controlled Clinical Trial
Brief Summary

A controlled, randomized study on the treatment of schizophrenic psychosis with cannabidiol, a phytocannabinoid is performed. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia. Our group has shown, for example, that Δ9-tetrahydrocannabinol (Δ9-THC) is able to provoke schizophrenia-like psychotic symptoms in healthy volunteers. This, as well as the capability of Δ9-THC to exacerbate productive psychotic symptoms in schizophrenic patients, has recently been confirmed by others. Furthermore, we found that the en-dogenous brain constituent anandamide, an endogenous Δ9-THC agonist, is significantly elevated in the CSF of schizophrenic patients. Cannabinergic substances such as anandamide may enhance dopaminergic neurotrans-mission by increasing dopamine turnover. They may also influence the onset or course of schizophrenia by as yet unidentified mechanisms We seek to investigate the efficacy of cannabidiol in the treatment of schizophrenic and schizophreniform psy-choses, because there is evidence that CB1 antagonists such as SR141716 and cannabidiol have antipsychotic effects comparable to those of classic neuroleptic drugs. Furthermore, cannabidiol is well tolerated showing few side effects in humans. Cannabidiol may serve as an antipsychotic medication that is not primarily based upon an antidopaminergic but upon different mechanisms, especially anticannabinergic ones. It may therefore be an effec-tive medication in at least a subgroup of schizophrenic and schizophreniform patients and may be expected to show additional anxiolytic effects and only minor side effects.

The control condition in this parallel design will be an established neuroleptic treatment with amisulpride that is primarely an antidopaminergic drug. Thus, we will study not only the antipsychotic efficacy of cannabidiol, but we will also compare the effects of both treatment strategies on side effects and neuropsychological functioning.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Cannabidiol
    Capsules, 3 times daily, 200 mg, 4 weeks
  • Drug: Amisulpride
    Capsules, 3 times daily, 200 mg, 4 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Cannabidiol
  • Active Comparator: 2
    Intervention: Drug: Amisulpride
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
Estimated Enrollment  ICMJE
 (submitted: February 26, 2008)
42
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia or schizophreniform psychosis according to DSM-IV.
  • BPRS score >36 and BPRS psychosis cluster > 12.
  • Ability to provide written informed consent.
  • Participants are required an adequate contraception.

Exclusion Criteria:

  • Any severe neurological or somatic disorder.
  • Other psychiatric disorders including addictive disorders.
  • Positive urine drug screening for any compound except benzodiazepines.
  • No pregnancy or breast feeding.
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 NCT00628290
Other Study ID Numbers  ICMJE CBD-CT1
SMRI Grant ID: 00-093
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. F. Markus Leweke, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Franz-Markus Leweke, MD University of Cologne, Dept. of Psychiatry and Psychotherapy
PRS Account University of Cologne
Verification Date January 2008

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