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: 17.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations
MedDRA version: 17.0Level: SOCClassification code 10018065Term: General disorders and administration site conditionsSystem Organ Class: 10018065 - General disorders and administration site conditions
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-004335-23-DE

Lead Sponsor: Central Institute of Mental Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy of cannabidiol in alleviating the positive, negative and general symptoms of schizophrenia compared to olanzapine and placebo. <br>;Secondary Objective: Test of the efficacy and safety of cannabidiol, a potential enhancer of endocannabinoid action, in comparison to placebo and olanzapine in patients suffering from acute schizophrenia who are within the first three years of illness.<br>Impact of cannabidiol on metabolic functioning in comparison to placebo and olanzapine.<br>Quantification of the incidence of extrapyramidal unwanted effects following cannabidiol treatment in comparison to placebo and olanzapine;<br>Exploration of the relationship between symptom severity and plasma levels of cannabidiol and/or endocannabinoids.<br>;Primary end point(s): Change in the PANSS total score from baseline to week 4 of treatment;Timepoint(s) of evaluation of this end point: Day 28

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Day 28;Secondary end point(s): • Changes from baseline in the PANSS subscores and clusters<br>• Changes from baseline in the Clinical Global Impression score (CGI)<br>• Proportion of responders defined as (1) at least 30 % decrease in the PANSS score and (2) score of 1 or 2 on the CGI score<br>• Changes from baseline in the Calgary Depression Scale for Schizo-phrenia (CDSS)<br>• Changes from baseline in weight, waist circumference, fasting blood glucose levels, HBA1C, HDL/LDL cholesterole, and triglyceride levels as well as prolactine levels<br>• Proportion of subjects considered to be in remission<br>•Time to readiness for hospital discharge<br>• Time to maintained response and time to all cause discontinuation<br>• Subject’s Response to Antipsychotic (SRA) medication<br>• Subject’s treatment satisfaction questionnaire<br>and Subjective Well-Being under Neuroleptics (SWN)<br>• Medication Adherence Rating Scale (MARS)<br>

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