MedDataX Logo

A Clinical Trial on the Antipsychotic Properties of Cannabidiol

NCT ID: NCT00309413

Last Updated: 2008-07-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Psychotic Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Schizophrenia and Disorders with Psychotic Features

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Cannabidiol/Placebo

Group Type ACTIVE_COMPARATOR

Cannabidiol/Placebo

Intervention Type DRUG

600 mg/day, oral, capsules, 2 weeks, than cross-over

2

Placebo/Cannabidiol

Group Type PLACEBO_COMPARATOR

Placebo/Cannabidiol

Intervention Type DRUG

600 mg/day, oral, capsules, 2 weeks, than cross-over

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo/Cannabidiol

600 mg/day, oral, capsules, 2 weeks, than cross-over

Intervention Type DRUG

Cannabidiol/Placebo

600 mg/day, oral, capsules, 2 weeks, than cross-over

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Coordinating Centre for Clinical Trials Cologne

OTHER

Sponsor Role collaborator

University of Cologne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Cologne

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

F. Markus Leweke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Cologne, Dept. of Psychiatry and Psychotherapy

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CBD-PT 04-153

Identifier Type: -

Identifier Source: org_study_id