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

Sponsor

Central Institute of Mental Health, Mannheim (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02088060

Collaborator

Martin-Luther-Universität Halle-Wittenberg (Other), Heidelberg University (Other), Technische Universität München (Other), Ludwig-Maximilians - University of Munich (Other), Glostrup University Hospital, Copenhagen (Other)

150

Enrollment

Locations

Arms

101

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Cannabidiol Drug: Olanzapine Drug: Placebo Cannabidiol Drug: Placebo Olanzapine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cannabidiol Cannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks	Drug: Cannabidiol Cannabidiol capsules Drug: Placebo Olanzapine Placebo olanzapine capsules
Active Comparator: Olanzapine Olanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks	Drug: Olanzapine Olanzapine capsules Other Names: Olanzapine 1A pharma Drug: Placebo Cannabidiol Placebo cannabidiol capsules
Placebo Comparator: Placebo Placebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks	Drug: Placebo Cannabidiol Placebo cannabidiol capsules Drug: Placebo Olanzapine Placebo olanzapine capsules

Arm

Intervention/Treatment

Experimental: Cannabidiol

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

Drug: Cannabidiol

Cannabidiol capsules

Drug: Placebo Olanzapine

Placebo olanzapine capsules

Active Comparator: Olanzapine

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

Drug: Olanzapine

Olanzapine capsules

Other Names:

Olanzapine 1A pharma

Drug: Placebo Cannabidiol

Placebo cannabidiol capsules

Placebo Comparator: Placebo

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

Drug: Placebo Cannabidiol

Placebo cannabidiol capsules

Drug: Placebo Olanzapine

Placebo olanzapine capsules

Outcome Measures

Primary Outcome Measures

Change in the Positive and Negative Syndrome Scale (PANSS) total score [within 4 weeks]

Secondary Outcome Measures

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]
Changes in the Hamilton Anxiety Scale [within 4 weeks]
Changes in cognitive skills [within 4 weeks]
Response to antipsychotic medication [within 4 weeks]
Plasma levels of endogenous cannabinoids [within 4 weeks]
Changes in physiological parameter [within 4 weeks]
Changes in the UKU Side Effect Rating Scale [within 4 weeks]
Columbia Suicidality Severity Rating Scale [within 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatric Centre Glostrup	Glostrup		Denmark	2600
2	Department of General Psychiatry, Heidelberg University	Heidelberg	BW	Germany	68115
3	Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health	Mannheim	BW	Germany	68159
4	Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich	Munich	BY	Germany	80336
5	Dept. of Psychiatry and Psychotherapy, Technical University Munich	Munich	BY	Germany	81675
6	Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg	Halle	Saint	Germany	06112

Sponsors and Collaborators

Central Institute of Mental Health, Mannheim
Martin-Luther-Universität Halle-Wittenberg
Heidelberg University
Technische Universität München
Ludwig-Maximilians - University of Munich
Glostrup University Hospital, Copenhagen

Investigators

Principal Investigator: F. Markus Leweke, MD, Central Institute of Mental Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Central Institute of Mental Health, Mannheim

ClinicalTrials.gov Identifier:

NCT02088060

Other Study ID Numbers:

CBD-FEP
2012-004335-23

First Posted:

Mar 14, 2014

Last Update Posted:

Apr 27, 2021

Last Verified:

Apr 1, 2021

Additional relevant MeSH terms:

Schizophrenia

Cannabidiol

Olanzapine

Study Results

No Results Posted as of Apr 27, 2021