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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00309413 |
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Date of registration:
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30/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Clinical Trial on the Antipsychotic Properties of Cannabidiol
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Scientific title:
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A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00309413 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Contacts
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Name:
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F. Markus Leweke, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cologne |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psychotic Disorders
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Schizophrenia
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Intervention(s)
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Drug: Placebo/Cannabidiol
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Drug: Cannabidiol/Placebo
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Primary Outcome(s)
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BPRS
[Time Frame: 2 x 2 weeks]
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Secondary Outcome(s)
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PANSS, EPS, Prolactin, ECG etc.
[Time Frame: 2 x 2 weeks]
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Secondary ID(s)
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CBD-PT 04-153
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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