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A Clinical Trial on the Antipsychotic Properties of Cannabidiol

Primary Purpose

Schizophrenia, Psychotic Disorders

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Placebo/Cannabidiol
Cannabidiol/Placebo
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia and Disorders with Psychotic Features

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cologne, Dept. of Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Cannabidiol/Placebo

Placebo/Cannabidiol

Outcomes

Primary Outcome Measures

BPRS

Secondary Outcome Measures

PANSS, EPS, Prolactin, ECG etc.

Full Information

First Posted
March 30, 2006
Last Updated
July 23, 2008
Sponsor
University of Cologne
Collaborators
Stanley Medical Research Institute, Coordinating Centre for Clinical Trials Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT00309413
Brief Title
A Clinical Trial on the Antipsychotic Properties of Cannabidiol
Official Title
A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cologne
Collaborators
Stanley Medical Research Institute, Coordinating Centre for Clinical Trials Cologne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders
Keywords
Schizophrenia and Disorders with Psychotic Features

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Cannabidiol/Placebo
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo/Cannabidiol
Intervention Type
Drug
Intervention Name(s)
Placebo/Cannabidiol
Intervention Description
600 mg/day, oral, capsules, 2 weeks, than cross-over
Intervention Type
Drug
Intervention Name(s)
Cannabidiol/Placebo
Intervention Description
600 mg/day, oral, capsules, 2 weeks, than cross-over
Primary Outcome Measure Information:
Title
BPRS
Time Frame
2 x 2 weeks
Secondary Outcome Measure Information:
Title
PANSS, EPS, Prolactin, ECG etc.
Time Frame
2 x 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Markus Leweke, MD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cologne, Dept. of Psychiatry and Psychotherapy
City
Cologne
State/Province
NRW
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial on the Antipsychotic Properties of Cannabidiol

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