A Clinical Trial on the Antipsychotic Properties of Cannabidiol

This study has been completed.

Sponsor:

Collaborators:

Stanley Medical Research Institute

Coordinating Centre for Clinical Trials Cologne

Information provided by:

University of Cologne

ClinicalTrials.gov Identifier:

NCT00309413

First received: March 30, 2006

Last updated: July 23, 2008

Last verified: July 2008

History of Changes

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Psychotic Disorders	Drug: Placebo/Cannabidiol Drug: Cannabidiol/Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:

BPRS [ Time Frame: 2 x 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PANSS, EPS, Prolactin, ECG etc. [ Time Frame: 2 x 2 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	29
Study Start Date:	March 2006
Study Completion Date:	July 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309413

Locations


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

Sponsors and Collaborators

University of Cologne

Stanley Medical Research Institute

Coordinating Centre for Clinical Trials Cologne

Investigators


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

More Information

No publications provided


Responsible Party:	F. Markus Leweke, M.D., University of Cologne
ClinicalTrials.gov Identifier:	NCT00309413 History of Changes
Other Study ID Numbers:	CBD-PT 04-153
Study First Received:	March 30, 2006
Last Updated:	July 23, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:


Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:


Psychotic Disorders Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 27, 2015

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