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

Primary Purpose

Schizophrenia

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Cannabidiol

Olanzapine

Placebo Cannabidiol

Placebo Olanzapine

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Psychiatric Centre Glostrup
Department of General Psychiatry, Heidelberg University
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health
Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich
Dept. of Psychiatry and Psychotherapy, Technical University Munich
Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Cannabidiol

Olanzapine

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in the PANSS subscores and clusters

Changes in the Clinical Global Impression score

Changes in the Global Assessment of Functioning Scale

Changes in the Personal and Social Performance Scale

Changes in the Calgary Depression Scale for Schizophrenia

Changes in the Hamilton Anxiety Scale

Changes in cognitive skills

Response to antipsychotic medication

Plasma levels of endogenous cannabinoids

Changes in physiological parameter

Changes in the UKU Side Effect Rating Scale

Columbia Suicidality Severity Rating Scale

Full Information

NCT ID

NCT02088060

First Posted

March 12, 2014

Last Updated

April 26, 2021

Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

Martin-Luther-Universität Halle-Wittenberg, Heidelberg University, Technical University of Munich, Ludwig-Maximilians - University of Munich, Glostrup University Hospital, Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT02088060

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

Martin-Luther-Universität Halle-Wittenberg, Heidelberg University, Technical University of Munich, Ludwig-Maximilians - University of Munich, Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cannabidiol

Arm Type

Experimental

Arm Description

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

Arm Title

Olanzapine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cannabidiol

Intervention Description

Cannabidiol capsules

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Other Intervention Name(s)

Olanzapine 1A pharma

Intervention Description

Olanzapine capsules

Intervention Type

Drug

Intervention Name(s)

Placebo Cannabidiol

Intervention Description

Placebo cannabidiol capsules

Intervention Type

Drug

Intervention Name(s)

Placebo Olanzapine

Intervention Description

Placebo olanzapine capsules

Primary Outcome Measure Information:

Title

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

Time Frame

within 4 weeks

Secondary Outcome Measure Information:

Title

Changes in the PANSS subscores and clusters

Time Frame

within 4 weeks

Title

Changes in the Clinical Global Impression score

Time Frame

within 4 weeks

Title

Changes in the Global Assessment of Functioning Scale

Time Frame

within 4 weeks

Title

Changes in the Personal and Social Performance Scale

Time Frame

within 4 weeks

Title

Changes in the Calgary Depression Scale for Schizophrenia

Time Frame

within 4 weeks

Title

Changes in the Hamilton Anxiety Scale

Time Frame

within 4 weeks

Title

Changes in cognitive skills

Time Frame

within 4 weeks

Title

Response to antipsychotic medication

Time Frame

within 4 weeks

Title

Plasma levels of endogenous cannabinoids

Time Frame

within 4 weeks

Title

Changes in physiological parameter

Time Frame

within 4 weeks

Title

Changes in the UKU Side Effect Rating Scale

Time Frame

within 4 weeks

Title

Columbia Suicidality Severity Rating Scale

Time Frame

within 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

F. Markus Leweke, MD

Organizational Affiliation

Central Institute of Mental Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Psychiatric Centre Glostrup

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Department of General Psychiatry, Heidelberg University

City

Heidelberg

State/Province

ZIP/Postal Code

68115

Country

Germany

Facility Name

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

City

Mannheim

State/Province

ZIP/Postal Code

68159

Country

Germany

Facility Name

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

City

Munich

State/Province

ZIP/Postal Code

80336

Country

Germany

Facility Name

Dept. of Psychiatry and Psychotherapy, Technical University Munich

City

Munich

State/Province

ZIP/Postal Code

81675

Country

Germany

Facility Name

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

City

Halle

State/Province

Saint

ZIP/Postal Code

06112

Country

Germany

12. IPD Sharing Statement

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

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