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

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00628290
First received: February 26, 2008
Last updated: March 17, 2008
Last verified: January 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Drug: Cannabidiol
Drug: Amisulpride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Antipsychotic Efficacy of the Phytocannabinoid Cannabidiol in Treating Acute Schizophrenic Psychosis. A Double-Blind, Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Change in BPRS total value. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in PANSS scores. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • EPS [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Weight gain [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Prolactin levels in serum [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: October 2002
Study Completion Date: March 2008
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Cannabidiol
Capsules, 3 times daily, 200 mg, 4 weeks
Active Comparator: 2 Drug: Amisulpride
Capsules, 3 times daily, 200 mg, 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628290

Locations
Germany
University of Cologne, Dept. of Psychiatry and Psychotherapy
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Franz-Markus Leweke, MD University of Cologne, Dept. of Psychiatry and Psychotherapy
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. F. Markus Leweke, University of Cologne
ClinicalTrials.gov Identifier: NCT00628290     History of Changes
Other Study ID Numbers: CBD-CT1, SMRI Grant ID: 00-093
Study First Received: February 26, 2008
Last Updated: March 17, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Sultopride
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013