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Enhancing Recovery in Early Schizophrenia

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ClinicalTrials.gov Identifier: NCT02926859
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

Study Description
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Brief Summary:
Current antipsychotic treatments of schizophrenia 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 and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Cannabidiol as add-on Drug: Placebo as add-on Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Recovery in Early Schizophrenia - a Multi-center, Two-arm, Double-blind, Randomized Phase II Trial Investigating Cannabidiol vs. Placebo as an add-on to an Individualized Antipsychotic Treatment
Actual Study Start Date : April 8, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabidiol
Cannabidiol as add-on to individualized pharmacological treatment
 Drug: Cannabidiol as add-on
Cannabidiol capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks
Placebo Comparator: Placebo
Placebo as add-on to individualized pharmacological treatment
 Drug: Placebo as add-on
Placebo capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks


Outcome Measures
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Primary Outcome Measures :
  1. All-cause discontinuation [ Time Frame: within 12 month ]

Secondary Outcome Measures :
  1. Improvement in Psychopathology assessed by PANSS [ Time Frame: 6, 9 and 12 month ]
    Positive and Negative Syndrome Scale (PANSS)

  2. Improvement in Psychopathology assessed by CGI [ Time Frame: 6, 9 and 12 month ]
    Clinical Global Impression (CGI)

  3. Improvement in Psychopathology assessed by BSI-53 [ Time Frame: 6, 9 and 12 month ]
    Brief Symptom Inventory (BSI-53)

  4. Improvement in Psychopathology assessed by FROGS [ Time Frame: 6, 9 and 12 month ]
    Functional Remission of General Schizophrenia (FROGS)

  5. Changes from baseline in Depression Scale [ Time Frame: 6, 9 and 12 month ]
    Calgary Depression Scale for Schizophrenia (CDSS)

  6. Improvement in social and occupational functioning assessed by GAF [ Time Frame: 6, 9 and 12 month ]
    Global Assessment of Functioning (GAF)

  7. Improvement in social and occupational functioning assessed by PSP [ Time Frame: 6, 9 and 12 month ]
    Personal and Social Performance Scale (PSP)

  8. Improvement in social and occupational functioning assessed by EMA [ Time Frame: 6, 9 and 12 month ]
    Ecological Momentary Assessment (EMA)

  9. Improvement in Quality of life assessed by WHOQUOL-Bref [ Time Frame: 6, 9 and 12 month ]
    WHO Quality of Life-Bref (WHOQUOL-Bref)

  10. Improvement in Quality of life assessed by LQLP [ Time Frame: 6, 9 and 12 month ]
    Lancashire Quality of Life Profile (LQLP)

  11. Changes from baseline in Neurocognition assessed by B-CATS [ Time Frame: 6, 9 and 12 month ]
    Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)

  12. Changes from baseline in Neurocognition assessed by BACS [ Time Frame: 6, 9 and 12 month ]
    Brief Assessment of Cognition in Schizophrenia (BACS)

  13. Changes from baseline in Neurocognition assessed by UPSA-B [ Time Frame: 6, 9 and 12 month ]
    University of California San Diego Performance based Skills Assessment (UPSA-B)

  14. Changes from baseline in Neurocognition assessed by MASC [ Time Frame: 6, 9 and 12 month ]
    Movie for the Assessment of Social Cognition (MASC)

  15. Changes from baseline in Neurocognition assessed by PFA [ Time Frame: 6, 9 and 12 month ]
    Pictures of Facial Affect (PFA)

  16. Treatment adherence [ Time Frame: 6, 9 and 12 month ]
  17. Changes in Cumulative dose of concomitant or rescue medication [ Time Frame: 6, 9 and 12 month ]
  18. Changes of Biomarker: alterations of endocannabinoids and lipdomic profiling [ Time Frame: 6, 9 and 12 month ]

Other Outcome Measures:
  1. Side effects: weight gain [ Time Frame: 6, 9 and 12 month ]
    Body Mass Index, abdominal girth

  2. Side effects: Vital Signs [ Time Frame: 6, 9 and 12 month ]
    heart rate, blood pressure, electrocardiography

  3. Side effects: UKU Side Effect rating scale [ Time Frame: 6, 9 and 12 month ]
  4. Side effects: Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 6, 9 and 12 month ]
  5. Side effects: Evaluation of extrapyramidal symptoms (EPS) [ Time Frame: 6, 9 and 12 month ]
  6. Side effects: physical and neurological examination [ Time Frame: 6, 9 and 12 month ]
  7. Standard blood tests [ Time Frame: 6, 9 and 12 month ]
  8. Columbia Suicidality Sverity Rating Scale (C-SSRS) [ Time Frame: 6, 9 and 12 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 (295.10-30, 295.90)
  • First documented diagnosis of schizophrenia must not be no older than seven years.
  • Patients must receive a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine or risperidone (TAU: treatment as usual) at least 4 weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.
  • Initial PANSS total score of ≤ 75 at baseline.
  • proper contraception in female patients of childbearing potential
  • body mass index between 18 and 40.

Exclusion Criteria:

  • Lack of accountability
  • positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
  • serious suicidal risk at screening visit
  • other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
  • other relevant neurological or other medical disorders
  • pregnancy or lactation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926859


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

Locations
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Germany
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health Recruiting
Mannheim, BW, Germany, 68159
Contact: F. Markus Leweke, MD    +49 621 1703 ext 2761    leweke@cimh.de   
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, Charité, Campus Charité-Mitte Recruiting
Berlin, B, Germany, 10117
Contact: Henrik Walter, MD, PhD       henrik.walter@charite.de   
Principal Investigator: Henrik Walter, MD         
Department of Psychiatry Psychotherapy and Psychosomatics, RWTH Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Tanja Veselinovic, MD       tveselinovic@ukaachen.de   
Principal Investigator: Tanja Veselinovic, MD         
Dept. of Psychiatry and Psychotherapy Recruiting
Cologne, NRW, Germany, 50924
Contact: Frank Jessen, MD       frank.jessen@uk-koeln.de   
Principal Investigator: Frank Jessen, MD         
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Investigators
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Principal Investigator: F. Markus Leweke, MD Central Institute of Mental Health
More Information
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Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT02926859     History of Changes
Other Study ID Numbers: CBD-ESPRIT
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Epidiolex
Anticonvulsants