A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol as a Treatment for Acutely Ill Schizophrenic Patients

Schizophrenia Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02088060
• Other study ID #: CBD-FEP
• Secondary ID: 2012-004335-23
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 8, 2015
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's population. Current antipsychotics are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9-tetrahydrocannabinol. While cannabidiol has no psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute paranoid schizophrenics the investigators showed a significant clinical improvement in all symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol displayed a significantly superior side-effect profile. This study is to evaluate the efficacy and safety of this novel treatment option in comparison to placebo and olanzapine, an established second generation antipsychotic in the treatment of acute schizophrenia and schizophrenia maintenance therapy, in a four-week clinical trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Exclusion Criteria:

• Lack of accountability (assessed by an independent psychiatrist)

• History of treatment-resistant schizophrenia, defined as no response 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 (Subject to investigator's and independent psychiatrist's judgement: Poses a serious suicidal or homicidal risk at screening visit or has made a serious suicide attempt within the last 12 months prior to screening visit, or has exhibited homicidal behaviour at anytime during her/his lifetime)

• Known intolerance or allergy to olanzapine or cannabidiol

• Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia

• Pregnancy, as determined through a ß-HCG pregnancy test, or lactation

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Cannabidiol
Cannabidiol capsules
• Olanzapine
Olanzapine capsules
• Placebo Cannabidiol
Placebo cannabidiol capsules
• Placebo Olanzapine
Placebo olanzapine capsules

Locations

Country	Name	City	State
Denmark	Psychiatric Centre Glostrup	Glostrup
Germany	Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg	Halle	Saint
Germany	Department of General Psychiatry, Heidelberg University	Heidelberg	BW
Germany	Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health	Mannheim	BW
Germany	Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich	Munich	BY
Germany	Dept. of Psychiatry and Psychotherapy, Technical University Munich	Munich	BY

Sponsors (6)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	Glostrup University Hospital, Copenhagen, Heidelberg University, Ludwig-Maximilians - University of Munich, Martin-Luther-Universität Halle-Wittenberg, Technical University of Munich

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Positive and Negative Syndrome Scale (PANSS) total score		within 4 weeks
Secondary	Changes in the PANSS subscores and clusters		within 4 weeks
Secondary	Changes in the Clinical Global Impression score		within 4 weeks
Secondary	Changes in the Global Assessment of Functioning Scale		within 4 weeks
Secondary	Changes in the Personal and Social Performance Scale		within 4 weeks
Secondary	Changes in the Calgary Depression Scale for Schizophrenia		within 4 weeks
Secondary	Changes in the Hamilton Anxiety Scale		within 4 weeks
Secondary	Changes in cognitive skills		within 4 weeks
Secondary	Response to antipsychotic medication		within 4 weeks
Secondary	Plasma levels of endogenous cannabinoids		within 4 weeks
Secondary	Changes in physiological parameter		within 4 weeks
Secondary	Changes in the UKU Side Effect Rating Scale		within 4 weeks
Secondary	Columbia Suicidality Severity Rating Scale		within 4 weeks