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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.
See 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
  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:


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