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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

Tracking Information
First Submitted Date  ICMJE July 7, 2016
First Posted Date  ICMJE October 6, 2016
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE April 8, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
All-cause discontinuation [ Time Frame: within 12 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02926859 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • Improvement in Psychopathology assessed by PANSS [ Time Frame: 6, 9 and 12 month ]
    Positive and Negative Syndrome Scale (PANSS)
  • Improvement in Psychopathology assessed by CGI [ Time Frame: 6, 9 and 12 month ]
    Clinical Global Impression (CGI)
  • Improvement in Psychopathology assessed by BSI-53 [ Time Frame: 6, 9 and 12 month ]
    Brief Symptom Inventory (BSI-53)
  • Improvement in Psychopathology assessed by FROGS [ Time Frame: 6, 9 and 12 month ]
    Functional Remission of General Schizophrenia (FROGS)
  • Changes from baseline in Depression Scale [ Time Frame: 6, 9 and 12 month ]
    Calgary Depression Scale for Schizophrenia (CDSS)
  • Improvement in social and occupational functioning assessed by GAF [ Time Frame: 6, 9 and 12 month ]
    Global Assessment of Functioning (GAF)
  • Improvement in social and occupational functioning assessed by PSP [ Time Frame: 6, 9 and 12 month ]
    Personal and Social Performance Scale (PSP)
  • Improvement in social and occupational functioning assessed by EMA [ Time Frame: 6, 9 and 12 month ]
    Ecological Momentary Assessment (EMA)
  • Improvement in Quality of life assessed by WHOQUOL-Bref [ Time Frame: 6, 9 and 12 month ]
    WHO Quality of Life-Bref (WHOQUOL-Bref)
  • Improvement in Quality of life assessed by LQLP [ Time Frame: 6, 9 and 12 month ]
    Lancashire Quality of Life Profile (LQLP)
  • Changes from baseline in Neurocognition assessed by B-CATS [ Time Frame: 6, 9 and 12 month ]
    Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
  • Changes from baseline in Neurocognition assessed by BACS [ Time Frame: 6, 9 and 12 month ]
    Brief Assessment of Cognition in Schizophrenia (BACS)
  • 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)
  • Changes from baseline in Neurocognition assessed by MASC [ Time Frame: 6, 9 and 12 month ]
    Movie for the Assessment of Social Cognition (MASC)
  • Changes from baseline in Neurocognition assessed by PFA [ Time Frame: 6, 9 and 12 month ]
    Pictures of Facial Affect (PFA)
  • Treatment adherence [ Time Frame: 6, 9 and 12 month ]
  • Changes in Cumulative dose of concomitant or rescue medication [ Time Frame: 6, 9 and 12 month ]
  • Changes of Biomarker: alterations of endocannabinoids and lipdomic profiling [ Time Frame: 6, 9 and 12 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • Improvement in Psychopathology assessed by PANSS [ Time Frame: 6, 9 and 12 month ]
    PANSS
  • Improvement in Psychopathology assessed by CGI [ Time Frame: 6, 9 and 12 month ]
    CGI
  • Improvement in Psychopathology assessed by BSI-53 [ Time Frame: 6, 9 and 12 month ]
    BSI-53
  • Improvement in Psychopathology assessed by FROGS [ Time Frame: 6, 9 and 12 month ]
    FROGS
  • Changes from baseline in Depression Scale [ Time Frame: 6, 9 and 12 month ]
    CDSS
  • Improvement in social and occupational functioning assessed by GAF [ Time Frame: 6, 9 and 12 month ]
    GAF
  • Improvement in social and occupational functioning assessed by PSP [ Time Frame: 6, 9 and 12 month ]
    PSP
  • Improvement in social and occupational functioning assessed by EMA [ Time Frame: 6, 9 and 12 month ]
    EMA
  • Improvement in Quality of life assessed by WHOQUOL-Bref [ Time Frame: 6, 9 and 12 month ]
    WHOQUOL-Bref
  • Improvement in Quality of life assessed by LQLP [ Time Frame: 6, 9 and 12 month ]
    WHOQUOL-Bref
  • Changes from baseline in Neurocognition assessed by B-CATS [ Time Frame: 6, 9 and 12 month ]
    B-CATS
  • Changes from baseline in Neurocognition assessed by BACS [ Time Frame: 6, 9 and 12 month ]
    BACS
  • Changes from baseline in Neurocognition assessed by UPSA-B [ Time Frame: 6, 9 and 12 month ]
    UPSA-B
  • Changes from baseline in Neurocognition assessed by MASC [ Time Frame: 6, 9 and 12 month ]
    MASC
  • Changes from baseline in Neurocognition assessed by PFA [ Time Frame: 6, 9 and 12 month ]
    PFA
  • Treatment adherence [ Time Frame: 6, 9 and 12 month ]
  • Changes in Cumulative dose of concomitant or rescue medication [ Time Frame: 6, 9 and 12 month ]
  • Changes of Biomarker [ Time Frame: 6, 9 and 12 month ]
Current Other Pre-specified Outcome Measures
 (submitted: October 24, 2016)
  • Side effects: weight gain [ Time Frame: 6, 9 and 12 month ]
    Body Mass Index, abdominal girth
  • Side effects: Vital Signs [ Time Frame: 6, 9 and 12 month ]
    heart rate, blood pressure, electrocardiography
  • Side effects: UKU Side Effect rating scale [ Time Frame: 6, 9 and 12 month ]
  • Side effects: Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 6, 9 and 12 month ]
  • Side effects: Evaluation of extrapyramidal symptoms (EPS) [ Time Frame: 6, 9 and 12 month ]
  • Side effects: physical and neurological examination [ Time Frame: 6, 9 and 12 month ]
  • Standard blood tests [ Time Frame: 6, 9 and 12 month ]
  • Columbia Suicidality Sverity Rating Scale (C-SSRS) [ Time Frame: 6, 9 and 12 month ]
Original Other Pre-specified Outcome Measures
 (submitted: October 4, 2016)
  • Side effects [ Time Frame: 6, 9 and 12 month ]
    EPS, AIMS, UKU, BMI, ECG, C-SSRS, prolactin
  • Standard blood tests [ Time Frame: 6, 9 and 12 month ]
 
Descriptive Information
Brief Title  ICMJE Enhancing Recovery in Early Schizophrenia
Official Title  ICMJE 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
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.
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 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
  • 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
Study Arms  ICMJE
  • Experimental: Cannabidiol
    Cannabidiol as add-on to individualized pharmacological treatment
    Intervention: Drug: Cannabidiol as add-on
  • Placebo Comparator: Placebo
    Placebo as add-on to individualized pharmacological treatment
    Intervention: Drug: Placebo as add-on
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2016)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (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 (295.10-30, 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.
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: F. Markus Leweke, MD +49 621 1703 2321 leweke@cimh.de
Contact: Cathrin Rohleder, PhD +49 621 1703 2333 rohleder@cimh.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02926859
Other Study ID Numbers  ICMJE CBD-ESPRIT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 Not Provided
Investigators  ICMJE
Principal Investigator: F. Markus Leweke, MD Central Institute of Mental Health
PRS Account Central Institute of Mental Health, Mannheim
Verification Date May 2019

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