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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 : March 8, 2018
Sponsor:
Collaborator:
Max-Planck Institute for Metabolism Research
Information provided by (Responsible Party):
F Markus Leweke, Central Institute of Mental Health, Mannheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: URB597 Drug: intranasal Insulin Drug: Cannabidiol CR Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Potential Central Glucoregulatory Compounds to Treat/Ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers.
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Insulin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intranasal Insulin
Intranasal administered insulin
 Drug: intranasal Insulin
160 IU / d for 5 days, intranasal
Experimental: Cannabidiol CR
Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant.
 Drug: Cannabidiol CR
320 mg / d for 5 days, orally
Other Name: Arvisol
Experimental: URB597
URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme.
 Drug: URB597
10 mg / d for 5 days, orally


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels) [ Time Frame: Seven days ]
  3. Diagnostics of the cerebrospinal fluid [ Time Frame: Seven days ]
  4. fMRI scan of the brain [ Time Frame: Seven days ]

Secondary Outcome Measures :
  1. Regular evaluating of the subject's condition and ability to continue the study by CGI [ Time Frame: Seven days ]
  2. Regular laboratory testing and ECG [ Time Frame: Seven days ]
  3. Scales for the assessment of adverse events (UKU, SCL- 90-R) [ Time Frame: Seven days ]
  4. (Numbers of) SAE and AE [ Time Frame: Seven days ]

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:   Yes
Criteria

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)
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): NCT00916201


Contacts
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

Locations
Germany
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health Not yet 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: Cathrin Rohleder, PhD         
Sub-Investigator: Till van der List, MD         
Sub-Investigator: Juliane K. Mueller, MD         
Sub-Investigator: Frank Enning, MD         
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Max-Planck Institute for Metabolism Research
Investigators
Principal Investigator: F. Markus Leweke, MD Central Institute of Mental Health
More Information
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Responsible Party: F Markus Leweke, Professor, Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT00916201     History of Changes
Other Study ID Numbers: EICAS
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by F Markus Leweke, Central Institute of Mental Health, Mannheim:
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin, Globin Zinc
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs