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

This study is currently recruiting participants.

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Contacts and Locations

Verified September 2016 by Central Institute of Mental Health, Mannheim

Sponsor:

Collaborators:

Martin-Luther-Universität Halle-Wittenberg

Heidelberg University

Technische Universität München

Ludwig-Maximilians - University of Munich

Glostrup University Hospital, Copenhagen

Information provided by (Responsible Party):

Central Institute of Mental Health, Mannheim

ClinicalTrials.gov Identifier:

NCT02088060

First received: March 12, 2014

Last updated: September 30, 2016

Last verified: September 2016

History of Changes

Purpose

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	Intervention	Phase
Schizophrenia	Drug: Cannabidiol Drug: Olanzapine Drug: Placebo Cannabidiol Drug: Placebo Olanzapine	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine Olanzapine pamoate

U.S. FDA Resources

Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Changes in the PANSS subscores and clusters [ Time Frame: within 4 weeks ]
Changes in the Clinical Global Impression score [ Time Frame: within 4 weeks ]
Changes in the Global Assessment of Functioning Scale [ Time Frame: within 4 weeks ]
Changes in the Personal and Social Performance Scale [ Time Frame: within 4 weeks ]
Changes in the Calgary Depression Scale for Schizophrenia [ Time Frame: within 4 weeks ]
Changes in the Hamilton Anxiety Scale [ Time Frame: within 4 weeks ]
Changes in cognitive skills [ Time Frame: within 4 weeks ]
Response to antipsychotic medication [ Time Frame: within 4 weeks ]
Plasma levels of endogenous cannabinoids [ Time Frame: within 4 weeks ]
Changes in physiological parameter [ Time Frame: within 4 weeks ]
Changes in the UKU Side Effect Rating Scale [ Time Frame: within 4 weeks ]
Columbia Suicidality Severity Rating Scale [ Time Frame: within 4 weeks ]


Estimated Enrollment:	150
Study Start Date:	March 2014
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	August 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cannabidiol Cannabidiol tablets 300 mg twice a day and placebo olanzapine capsule once a day over 4 weeks	Drug: Cannabidiol Cannabidiol tablets Other Name: Arvisol Drug: Placebo Olanzapine Placebo olanzapine capsule
Active Comparator: Olanzapine Olanzapine capsule 15mg once a day and placebo cannabidiol tablets twice a day over 4 weeks	Drug: Olanzapine Olanzapine capsules Other Name: Olanzapine 1A pharma Drug: Placebo Cannabidiol Placebo cannabidiol tablets
Placebo Comparator: Placebo Placebo cannabidiol tablets twice a day and placebo olanzapine capsule once a day over 4 weeks	Drug: Placebo Cannabidiol Placebo cannabidiol tablets Drug: Placebo Olanzapine Placebo olanzapine capsule

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02088060

Contacts


Contact: F. Markus Leweke, MD	+49 621 1703 2321	leweke@cimh.de
Contact: Cathrin Rohleder, PhD	+49 621 1703 2333	rohleder@cimh.de

Locations


Denmark
Psychiatric Centre Glostrup	Recruiting
Glostrup, Denmark, 2600
Contact: Birte Glenthøj, MD Birte.Glenthoej@regionh.dk
Principal Investigator: Birte Glenthøj, MD
Germany
Department of General Psychiatry, Heidelberg University	Not yet recruiting
Heidelberg, BW, Germany, 68115
Contact: Dagmar Koethe, MD Dagmar.Koethe@med.uni-heidelberg.de
Principal Investigator: Dagmar Koethe, MD
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health	Recruiting
Mannheim, BW, Germany, 68159
Contact: F. Markus Leweke, MD +49 621 1703 ext 2321 leweke@cimh.de
Contact: Cathrin Rohleder, PhD +49 621 1703 ext 2333 rohleder@cimh.de
Sub-Investigator: J. Malte Bumb, MD
Sub-Investigator: Juliane K. Mueller, MD
Principal Investigator: F. Markus Leweke, MD
Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich	Not yet recruiting
Munich, BY, Germany, 80336
Contact: Peter Falkai, MD Peter.Falkai@med.uni-muenchen.de
Principal Investigator: Peter Falkai, MD
Dept. of Psychiatry and Psychotherapy, Technical University Munich	Not yet recruiting
Munich, BY, Germany, 81675
Contact: Stefan Leucht, MD Stefan.Leucht@lrz.tu-muenchen.de
Principal Investigator: Stefan Leucht, MD
Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg	Recruiting
Halle, ST, Germany, 06112
Contact: Dan Rujescu, MD dan.rujescu@uk-halle.de
Principal Investigator: Dan Rujescu, MD

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

More Information


Responsible Party:	Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:	NCT02088060 History of Changes
Other Study ID Numbers:	CBD-FEP 2012-004335-23 ( EudraCT Number )
Study First Received:	March 12, 2014
Last Updated:	September 30, 2016

Additional relevant MeSH terms:


Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents	Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents

ClinicalTrials.gov processed this record on August 22, 2017

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