A Clinical Trial on the Antipsychotic Properties of Cannabidiol

• ClinicalTrials.gov Identifier: NCT00309413
• Recruitment Status: Completed
• First Posted: March 31, 2006
• Last Update Posted: July 25, 2008
• Sponsor: University of Cologne
• Collaborators: Stanley Medical Research Institute; Coordinating Centre for Clinical Trials Cologne
• Information provided by: University of Cologne

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Psychotic Disorders	Drug: Placebo/Cannabidiol; Drug: Cannabidiol/Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: March 2006
• Actual Primary Completion Date: March 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. BPRS [ Time Frame: 2 x 2 weeks ]

Secondary Outcome Measures :

1. PANSS, EPS, Prolactin, ECG etc. [ Time Frame: 2 x 2 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: F. Markus Leweke, M.D., University of Cologne
• ClinicalTrials.gov Identifier: NCT00309413
• Other Study ID Numbers: CBD-PT 04-153
• First Posted: March 31, 2006
• Last Update Posted: July 25, 2008
• Last Verified: July 2008

Keywords provided by University of Cologne:

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Cannabidiol; Anticonvulsants