Status:
COMPLETED
A Clinical Trial on the Antipsychotic Properties of Cannabidiol
Lead Sponsor:
University of Cologne
Collaborating Sponsors:
Stanley Medical Research Institute
Coordinating Centre for Clinical Trials Cologne
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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, randomi...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00309413
Start Date
March 1 2006
End Date
July 1 2008
Last Update
July 25 2008
Active Locations (1)
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1
University of Cologne, Dept. of Psychiatry and Psychotherapy
Cologne, North Rhine-Westphalia, Germany, 50924