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

• Register: EUCTR
• Last refreshed on: 19 March 2018
• Main ID: EUCTR2012-004335-23-DE
• Date of registration: 19/08/2013
• Prospective Registration: Yes
• Primary sponsor: Central Institute of Mental Health
• Public title: A four-week clinical trial investigating efficacy and safety of cannabidiol as a treatment for acutely ill schizophrenic patients
• Scientific title: A four-week, multicentre, double-blinded, randomised, active- and placebo-controlled, parallel-group trial investigating efficacy and safety of cannabidiol in acute, early-stage schizophrenic patients
• Date of first enrolment: 30/12/2013
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004335-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark, Germany, Romania

Contacts

• Name: Referat Wissenschaft und Forschung
• Affiliation: Central Institute of Mental Health

• Name: Referat Wissenschaft und Forschung
• Affiliation: Central Institute of Mental Health

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Acute early-stage psychosis
MedDRA version: 17.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
MedDRA version: 17.0 Level: SOC Classification code 10018065 Term: General disorders and administration site conditions System Organ Class: 10018065 - General disorders and administration site conditions

Intervention(s)

Product Name: Cannabidiol (enhanced formulation)
Product Code: CBD CR
Pharmaceutical Form: Tablet
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Other descriptive name: CANNABIDIOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Olanzapin 1-A Pharma Filmtabletten
Product Name: Olanzapine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: Cannabidiol (enhanced formulation)
Product Code: CBD CR
Pharmaceutical Form: Tablet
CAS Number: 13956-29-1
Other descriptive name: CANNABIDIOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Day 28

Primary end point(s): Change in the PANSS total score from baseline to week 4 of treatment

Main Objective: Evaluation of the efficacy of cannabidiol in alleviating the positive, negative and general symptoms of schizophrenia compared to olanzapine and placebo.

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.
Impact of cannabidiol on metabolic functioning in comparison to placebo and olanzapine.
Quantification of the incidence of extrapyramidal unwanted effects following cannabidiol treatment in comparison to placebo and olanzapine;
Exploration of the relationship between symptom severity and plasma levels of cannabidiol and/or endocannabinoids.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Day 28

Secondary end point(s): • Changes from baseline in the PANSS subscores and clusters
• Changes from baseline in the Clinical Global Impression score (CGI)
• 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
• Changes from baseline in the Calgary Depression Scale for Schizo-phrenia (CDSS)
• Changes from baseline in weight, waist circumference, fasting blood glucose levels, HBA1C, HDL/LDL cholesterole, and triglyceride levels as well as prolactine levels
• Proportion of subjects considered to be in remission
•Time to readiness for hospital discharge
• Time to maintained response and time to all cause discontinuation
• Subject’s Response to Antipsychotic (SRA) medication
• Subject’s treatment satisfaction questionnaire
and Subjective Well-Being under Neuroleptics (SWN)
• Medication Adherence Rating Scale (MARS)

Secondary ID(s)

CBD-FEP

Source(s) of Monetary Support

European Commission