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Evaluation Study of New Compounds With Potential Use in Schizophrenia (EICAS)

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ClinicalTrials.gov Identifier: NCT00916201
Recruitment Status : Not yet recruiting
First Posted : June 9, 2009
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Max-Planck Institute for Metabolism Research
Information provided by (Responsible Party):
F Markus Leweke, Central Institute of Mental Health, Mannheim

Tracking Information
First Submitted Date  ICMJE May 5, 2009
First Posted Date  ICMJE June 9, 2009
Last Update Posted Date August 14, 2019
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
  • Clinical assessment with several psychopathological scores for self-assessment and peer evaluation (BPRS, PANSS, SIPS, CGI, MADRS, HAM-A, SCL-90-R) [ Time Frame: Seven days ]
  • Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels) [ Time Frame: Seven days ]
  • Diagnostics of the cerebrospinal fluid [ Time Frame: Seven days ]
  • fMRI scan of the brain [ Time Frame: Seven days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
  • Regular evaluating of the subject's condition and ability to continue the study by CGI [ Time Frame: Seven days ]
  • Regular laboratory testing and ECG [ Time Frame: Seven days ]
  • Scales for the assessment of adverse events (UKU, SCL- 90-R) [ Time Frame: Seven days ]
  • (Numbers of) SAE and AE [ Time Frame: Seven days ]
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 Evaluation Study of New Compounds With Potential Use in Schizophrenia
Official Title  ICMJE Evaluation of Potential Central Glucoregulatory Compounds to Treat/Ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers.
Brief Summary Different compounds that might modify the glucose regulation in the central nervous system will be evaluated in healthy volunteers. Several examinations will be performed in order to get a detailed plan how these substances might work.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: URB597
    10 mg / d for 5 days, orally
  • Drug: intranasal Insulin
    160 IU / d for 5 days, intranasal
  • Drug: Cannabidiol CR
    320 mg / d for 5 days, orally
    Other Name: Arvisol
Study Arms  ICMJE
  • Experimental: Intranasal Insulin
    Intranasal administered insulin
    Intervention: Drug: intranasal Insulin
  • Experimental: Cannabidiol CR
    Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant.
    Intervention: Drug: Cannabidiol CR
  • Experimental: URB597
    URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme.
    Intervention: Drug: URB597
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2009)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers
  • Informed consent given by the subject
  • Both, female and male subjects may participate
  • Age between 18 and 65 years
  • Negative drug-screening at the time of screening
  • In female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1.
  • Non-Smoker
  • Body Mass Index between 18 and 40.

Exclusion Criteria:

  • Lack of accountability
  • Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening
  • Any known psychiatric or neurological illness in the participant's history.
  • Known family history concerning psychiatric disorders
  • Relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
  • Pregnancy or lactation phase in female at the time of screening
  • Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
  • Consumption of any illegal drugs (except cannabis in history, see above)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00916201
Other Study ID Numbers  ICMJE EICAS
Has Data Monitoring Committee No
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 F Markus Leweke, Central Institute of Mental Health, Mannheim
Study Sponsor  ICMJE Central Institute of Mental Health, Mannheim
Collaborators  ICMJE Max-Planck Institute for Metabolism Research
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