A Clinical Trial on the Antipsychotic Properties of Cannabidiol

Schizophrenia Clinical Trial

Official title:

A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309413
• Other study ID #: CBD-PT 04-153
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2006
• Last updated: July 23, 2008
• Start date: March 2006
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• Placebo/Cannabidiol
600 mg/day, oral, capsules, 2 weeks, than cross-over
• Cannabidiol/Placebo
600 mg/day, oral, capsules, 2 weeks, than cross-over

Locations

Country	Name	City	State
Germany	University of Cologne, Dept. of Psychiatry and Psychotherapy	Cologne	NRW

Sponsors (3)

Lead Sponsor	Collaborator
University of Cologne	Coordinating Centre for Clinical Trials Cologne, Stanley Medical Research Institute

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BPRS		2 x 2 weeks	No
Secondary	PANSS, EPS, Prolactin, ECG etc.		2 x 2 weeks	Yes