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

NCT ID: NCT02088060

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-08
• Study Completion Date: 2024-09-16

Brief 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cannabidiol

Cannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Cannabidiol capsules

Placebo Olanzapine

Intervention Type: DRUG

Placebo olanzapine capsules

Olanzapine

Olanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks

Group Type: ACTIVE_COMPARATOR

Olanzapine

Intervention Type: DRUG

Olanzapine capsules

Placebo Cannabidiol

Intervention Type: DRUG

Placebo cannabidiol capsules

Placebo

Placebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo Cannabidiol

Intervention Type: DRUG

Placebo cannabidiol capsules

Placebo Olanzapine

Intervention Type: DRUG

Placebo olanzapine capsules

Interventions

Cannabidiol

Cannabidiol capsules

Intervention Type: DRUG

Olanzapine

Olanzapine capsules

Intervention Type: DRUG

Placebo Cannabidiol

Placebo cannabidiol capsules

Intervention Type: DRUG

Placebo Olanzapine

Placebo olanzapine capsules

Intervention Type: DRUG

Other Intervention Names

Olanzapine 1A pharma

Eligibility 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

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 β-HCG pregnancy test, or lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

F. Markus Leweke, MD

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health

Locations

Psychiatric Centre Glostrup

Glostrup Municipality, , Denmark

Department of General Psychiatry, Heidelberg University

Heidelberg, Baden-Wurttemberg, Germany

Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, Germany

Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich

Munich, Bavaria, Germany

Dept. of Psychiatry and Psychotherapy, Technical University Munich

Munich, Bavaria, Germany

Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg

Halle, Saxony-Anhalt, Germany

Countries

Denmark; Germany

Other Identifiers

2012-004335-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBD-FEP

Identifier Type: -

Identifier Source: org_study_id