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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2015 by Central Institute of Mental Health, Mannheim
Sponsor:
Collaborator:
Max-Planck Institute for Metabolism Research
Information provided by (Responsible Party):
F Markus Leweke, Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT00916201
First received: May 5, 2009
Last updated: August 13, 2015
Last verified: August 2015
History of Changes
  Purpose
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 Intervention Phase
Schizophrenia
 Drug: URB597
Drug: intranasal Insulin
Drug: Cannabidiol CR
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels) [ Time Frame: Seven days ] [ Designated as safety issue: No ]
  • Diagnostics of the cerebrospinal fluid [ Time Frame: Seven days ] [ Designated as safety issue: No ]
  • fMRI scan of the brain [ Time Frame: Seven days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Regular evaluating of the subject's condition and ability to continue the study by CGI [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]
  • Regular laboratory testing and ECG [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]
  • Scales for the assessment of adverse events (UKU, SCL- 90-R) [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]
  • (Numbers of) SAE and AE [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 86
Study Start Date: December 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: F Markus Leweke, Professor, Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT00916201     History of Changes
Other Study ID Numbers: EICAS 
Study First Received: May 5, 2009
Last Updated: August 13, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016