A four-week clinical trial investigating efficacy and safety of cannabidiol as a treatment for acutely ill schizophrenic patients

Phase 1

• Conditions: Acute early-stage psychosis; MedDRA version: 16.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations; MedDRA version: 16.1 Level: SOC Classification code 10018065 Term: General disorders and administration site conditions System Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-004335-23-DK
• Lead Sponsor: Central Institute of Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

•Informed consent given by the subject
•DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90) (American Psychiatric Association)
•Patients must be within the first three years of illness, i.e. first diagnosis of schizophrenia is no older than three years.
•Age 18 to 65 years, male or female
•Minimal initial PANSS score of 75 at baseline
•Female patients of childbearing potential need to utilize a proper method of contraception.
•Body Mass Index between 18 and 40

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Lack of accountability
•History of treatment-resistant schizophrenia, defined as no re-sponse to at least two antipsychotics given for a minimum of 6 weeks each in an adequate dosage
•Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
•Serious suicidal risk at screening visit
•Known intolerance or allergy to olanzapine or cannabidiol
•Other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia
•Pregnancy, as determined through a ß-HCG pregnancy test, or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified