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

NCT02088060 | Terminated Phase 2 DMC

• 2 other identifiers: CBD-FEP2012-004335-23
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Change in the Positive and Negative Syndrome Scale (PANSS) total score

  within 4 weeks

Secondary Outcomes (12)

• Changes in the PANSS subscores and clusters

  within 4 weeks

• Changes in the Clinical Global Impression score

  within 4 weeks

• Changes in the Global Assessment of Functioning Scale

  within 4 weeks

• Changes in the Personal and Social Performance Scale

  within 4 weeks

• Changes in the Calgary Depression Scale for Schizophrenia

  within 4 weeks

Study Arms (3)

Cannabidiol

EXPERIMENTAL

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

Drug: Cannabidiol; Drug: Placebo Olanzapine

Olanzapine

ACTIVE COMPARATOR

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

Drug: Olanzapine; Drug: Placebo Cannabidiol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Cannabidiol; Drug: Placebo Olanzapine

Interventions

Cannabidiol DRUG

Cannabidiol capsules

Cannabidiol

Olanzapine DRUG

Olanzapine capsules

Also known as: Olanzapine 1A pharma

Olanzapine

Placebo Cannabidiol DRUG

Placebo cannabidiol capsules

Olanzapine; Placebo

Placebo Olanzapine DRUG

Placebo olanzapine capsules

Cannabidiol; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• Martin-Luther-Universität Halle-Wittenberg: collaborator
• Heidelberg University: collaborator
• Technical University of Munich: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (6)

Psychiatric Centre Glostrup

Glostrup Municipality, 2600, Denmark

Location

Department of General Psychiatry, Heidelberg University

Heidelberg, Baden-Wurttemberg, 68115, Germany

Location

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

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

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

Munich, Bavaria, 80336, Germany

Location

Dept. of Psychiatry and Psychotherapy, Technical University Munich

Munich, Bavaria, 81675, Germany

Location

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

Halle, Saxony-Anhalt, 06112, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cannabidiol; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• F. Markus Leweke, MD

  Central Institute of Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: December 8, 2015
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

DK (1); DE (5)