Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis (CBD-CT1)

• ClinicalTrials.gov Identifier: NCT00628290
• Recruitment Status: Completed
• First Posted: March 5, 2008
• Last Update Posted: March 18, 2008
• Sponsor: University of Cologne
• Information provided by: University of Cologne

Tracking Information

• First Submitted Date: February 26, 2008
• First Posted Date: March 5, 2008
• Last Update Posted Date: March 18, 2008
• Study Start Date: October 2002
• Actual Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 26, 2008): Change in BPRS total value. [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00628290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: February 26, 2008)

• Change in PANSS scores. [ Time Frame: 4 weeks ]
• EPS [ Time Frame: 4 weeks ]
• Weight gain [ Time Frame: 4 weeks ]
• Prolactin levels in serum [ Time Frame: 4 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis
• Official Title: Evaluation of the Antipsychotic Efficacy of the Phytocannabinoid Cannabidiol in Treating Acute Schizophrenic Psychosis. A Double-Blind, Controlled Clinical Trial

Brief Summary

A controlled, randomized study on the treatment of schizophrenic psychosis with cannabidiol, a phytocannabinoid is performed. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia. Our group has shown, for example, that Δ9-tetrahydrocannabinol (Δ9-THC) is able to provoke schizophrenia-like psychotic symptoms in healthy volunteers. This, as well as the capability of Δ9-THC to exacerbate productive psychotic symptoms in schizophrenic patients, has recently been confirmed by others. Furthermore, we found that the en-dogenous brain constituent anandamide, an endogenous Δ9-THC agonist, is significantly elevated in the CSF of schizophrenic patients. Cannabinergic substances such as anandamide may enhance dopaminergic neurotrans-mission by increasing dopamine turnover. They may also influence the onset or course of schizophrenia by as yet unidentified mechanisms We seek to investigate the efficacy of cannabidiol in the treatment of schizophrenic and schizophreniform psy-choses, because there is evidence that CB1 antagonists such as SR141716 and cannabidiol have antipsychotic effects comparable to those of classic neuroleptic drugs. Furthermore, cannabidiol is well tolerated showing few side effects in humans. Cannabidiol may serve as an antipsychotic medication that is not primarily based upon an antidopaminergic but upon different mechanisms, especially anticannabinergic ones. It may therefore be an effec-tive medication in at least a subgroup of schizophrenic and schizophreniform patients and may be expected to show additional anxiolytic effects and only minor side effects.

The control condition in this parallel design will be an established neuroleptic treatment with amisulpride that is primarely an antidopaminergic drug. Thus, we will study not only the antipsychotic efficacy of cannabidiol, but we will also compare the effects of both treatment strategies on side effects and neuropsychological functioning.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Schizophrenia

Intervention

• Drug: Cannabidiol
  Capsules, 3 times daily, 200 mg, 4 weeks
• Drug: Amisulpride
  Capsules, 3 times daily, 200 mg, 4 weeks

Study Arms

• Experimental: 1
  Intervention: Drug: Cannabidiol
• Active Comparator: 2
  Intervention: Drug: Amisulpride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: February 26, 2008): 42
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2008
• Actual Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Clinical diagnosis of schizophrenia or schizophreniform psychosis according to DSM-IV.
• BPRS score >36 and BPRS psychosis cluster > 12.
• Ability to provide written informed consent.
• Participants are required an adequate contraception.

Exclusion Criteria:

• Any severe neurological or somatic disorder.
• Other psychiatric disorders including addictive disorders.
• Positive urine drug screening for any compound except benzodiazepines.
• No pregnancy or breast feeding.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00628290
• Other Study ID Numbers: CBD-CT1; SMRI Grant ID: 00-093
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. F. Markus Leweke, University of Cologne
• Study Sponsor: University of Cologne
• Collaborators: Not Provided

Investigators

• Principal Investigator: Franz-Markus Leweke, MD; University of Cologne, Dept. of Psychiatry and Psychotherapy

• PRS Account: University of Cologne
• Verification Date: January 2008