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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004335-23-DE

Enrollment

150

Registered

2013-08-19

Start date

2013-12-30

Completion date

Unknown

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 Concentrat

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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. ;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	—

Measure

Time frame

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. ;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

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Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Denmark, Germany, Romania

Contacts

Public ContactReferat Wissenschaft und Forschung

Central Institute of Mental Health

simone.fuchs@zi-mannheim.de+4962117031321

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026