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Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis

NCT00628290 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2008-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cannabidiol

Capsules, 3 times daily, 200 mg, 4 weeks

DRUG

Amisulpride

Capsules, 3 times daily, 200 mg, 4 weeks

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Franz-Markus Leweke, MD · University of Cologne, Dept. of Psychiatry and Psychotherapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2004-11-30
Completion
2008-03-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00628290 on ClinicalTrials.gov