A Clinical Trial on the Antipsychotic Properties of Cannabidiol

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Collaborators: Coordinating Centre for Clinical Trials Cologne; Stanley Medical Research Institute
• Treatments: Antipsychotic Agents; Cannabidiol

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