Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis - Full Text View

Sponsored by:	University of Cologne
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00628290

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 II

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Amisulpride Sultopride Cannabidiol

U.S. FDA Resources

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

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
1: Experimental	Drug: Cannabidiol Capsules, 3 times daily, 200 mg, 4 weeks
2: Active Comparator	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, NRW
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

Related Info This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders

Sultopride
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009