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Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis

NCT ID: NCT00628290

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Capsules, 3 times daily, 200 mg, 4 weeks

2

Group Type ACTIVE_COMPARATOR

Amisulpride

Intervention Type DRUG

Capsules, 3 times daily, 200 mg, 4 weeks

Interventions

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Cannabidiol

Capsules, 3 times daily, 200 mg, 4 weeks

Intervention Type DRUG

Amisulpride

Capsules, 3 times daily, 200 mg, 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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University of Cologne

Principal Investigators

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Franz-Markus Leweke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne, Dept. of Psychiatry and Psychotherapy

Locations

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University of Cologne, Dept. of Psychiatry and Psychotherapy

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Leweke FM, Rohleder C, Gerth CW, Hellmich M, Pukrop R, Koethe D. Cannabidiol and Amisulpride Improve Cognition in Acute Schizophrenia in an Explorative, Double-Blind, Active-Controlled, Randomized Clinical Trial. Front Pharmacol. 2021 Apr 29;12:614811. doi: 10.3389/fphar.2021.614811. eCollection 2021.

Reference Type DERIVED
PMID: 33995015 (View on PubMed)

Related Links

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http://www.ecnp.net

Related Info

Other Identifiers

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SMRI Grant ID: 00-093

Identifier Type: -

Identifier Source: secondary_id

CBD-CT1

Identifier Type: -

Identifier Source: org_study_id