Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088060
Recruitment Status : Active, not recruiting
First Posted : March 14, 2014
Last Update Posted : August 14, 2019
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

Tracking Information
First Submitted Date  ICMJE March 12, 2014
First Posted Date  ICMJE March 14, 2014
Last Update Posted Date August 14, 2019
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Change in the Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: within 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02088060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol as a Treatment for Acutely Ill Schizophrenic Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Cannabidiol
    Cannabidiol capsules
  • Drug: Olanzapine
    Olanzapine capsules
    Other Name: Olanzapine 1A pharma
  • Drug: Placebo Cannabidiol
    Placebo cannabidiol capsules
  • Drug: Placebo Olanzapine
    Placebo olanzapine capsules
Study Arms  ICMJE
  • Experimental: Cannabidiol
    Cannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks
    Interventions:
    • Drug: Cannabidiol
    • Drug: Placebo Olanzapine
  • Active Comparator: Olanzapine
    Olanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks
    Interventions:
    • Drug: Olanzapine
    • Drug: Placebo Cannabidiol
  • Placebo Comparator: Placebo
    Placebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks
    Interventions:
    • Drug: Placebo Cannabidiol
    • Drug: Placebo Olanzapine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088060
Other Study ID Numbers  ICMJE CBD-FEP
2012-004335-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Central Institute of Mental Health, Mannheim
Study Sponsor  ICMJE Central Institute of Mental Health, Mannheim
Collaborators  ICMJE
  • Martin-Luther-Universität Halle-Wittenberg
  • Heidelberg University
  • Technische Universität München
  • Ludwig-Maximilians - University of Munich
  • Glostrup University Hospital, Copenhagen
Investigators  ICMJE
Principal Investigator: F. Markus Leweke, MD Central Institute of Mental Health
PRS Account Central Institute of Mental Health, Mannheim
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP