A Clinical Trial on the Antipsychotic Properties of Cannabidiol

July 23, 2008 updated by: University of Cologne

A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol

The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite recent advances in the treatment of schizophrenia and schizophreniform disorders, there is still a need to develop efficient and better tolerated psychopharmacological approaches to this group of diseases. The endogenous cannabinoid system provides a promising target in the pharmacotherapy of these disorders. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia and that cannabidiol is effective in treating acute psychotic symptoms of schizophrenic patients. We will investigate cannabidiol versus placebo in a randomized, double blind design with extensive safety measures.

The primary hypothesis to be tested is that Cannabidiol is expected to be superior to placebo in the treatment of acute schizophrenic and schizophreniform psychoses with regard to its antipsychotic efficacy.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50924
        • University of Cologne, Dept. of Psychiatry and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV Diagnosis of schizophrenic or schizophreniform psychosis
  • Minimal initial score of 36 in the BPRS total score and a minimum of 12 in the BPRS Psychosis Cluster, including items 4 (conceptional disorganisation), 8 (exaggerated self-esteem), 12 (hallucinatory behaviour), and 15 (unusual thought content)
  • Exclusion of pregnancy in female subjects through negative β-HCG test

Exclusion Criteria:

  • Lack of accountability
  • Pregnancy or risk of pregnancy or lactation.
  • Other relevant interferences of axis 1 according to diagnostic evaluation through MINI including undifferentiated residual forms of schizophrenia.
  • Treatment with depot-antipsychotics during the last three months.
  • Severe internal or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures. Positive Hepatitis-serology.
  • QTc-elongation.
  • Acute suicidal tendency of or hazard to others by the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Cannabidiol/Placebo
Drug: Cannabidiol/Placebo
600 mg/day, oral, capsules, 2 weeks, than cross-over
PLACEBO_COMPARATOR: 2
Placebo/Cannabidiol
Drug: Placebo/Cannabidiol
600 mg/day, oral, capsules, 2 weeks, than cross-over

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BPRS
Time Frame: 2 x 2 weeks
2 x 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PANSS, EPS, Prolactin, ECG etc.
Time Frame: 2 x 2 weeks
2 x 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

Stanley Medical Research Institute
Coordinating Centre for Clinical Trials Cologne

Investigators

  • Principal Investigator: F. Markus Leweke, MD, University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

March 30, 2006

First Submitted That Met QC Criteria

March 30, 2006

First Posted (ESTIMATE)

March 31, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBD-PT 04-153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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