NCT00628290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

March 18, 2008

Status Verified

January 1, 2008

Enrollment Period

2.1 years

First QC Date

February 26, 2008

Last Update Submit

March 17, 2008

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change in BPRS total value.

    4 weeks

Secondary Outcomes (4)

  • Change in PANSS scores.

    4 weeks

  • EPS

    4 weeks

  • Weight gain

    4 weeks

  • Prolactin levels in serum

    4 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Cannabidiol

2

ACTIVE COMPARATOR
Drug: Amisulpride

Interventions

CannabidiolDRUG

Capsules, 3 times daily, 200 mg, 4 weeks

1
AmisulprideDRUG

Capsules, 3 times daily, 200 mg, 4 weeks

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne, Dept. of Psychiatry and Psychotherapy

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33995015DERIVED

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

CannabidiolAmisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic ChemicalsBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Franz-Markus Leweke, MD

    University of Cologne, Dept. of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 5, 2008

Study Start

October 1, 2002

Primary Completion

November 1, 2004

Study Completion

March 1, 2008

Last Updated

March 18, 2008

Record last verified: 2008-01

Locations

DE(1)