Evaluation Study of New Compounds With Potential Use in Schizophrenia (EICAS)
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
URB597
intranasal Insulin
Cannabidiol CR
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia
Eligibility 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)
Sites / Locations
- Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Intranasal Insulin
Cannabidiol CR
URB597
Arm Description
Intranasal administered insulin
Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant.
URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme.
Outcomes
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)
Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels)
Diagnostics of the cerebrospinal fluid
fMRI scan of the brain
Secondary Outcome Measures
Regular evaluating of the subject's condition and ability to continue the study by CGI
Regular laboratory testing and ECG
Scales for the assessment of adverse events (UKU, SCL- 90-R)
(Numbers of) SAE and AE
Full Information
NCT ID
NCT00916201
First Posted
May 5, 2009
Last Updated
August 12, 2019
Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
Max Planck Institute for Metabolism Research
1. Study Identification
Unique Protocol Identification Number
NCT00916201
Brief Title
Evaluation Study of New Compounds With Potential Use in Schizophrenia
Acronym
EICAS
Official Title
Evaluation of Potential Central Glucoregulatory Compounds to Treat/Ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
Max Planck Institute for Metabolism Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Insulin
Arm Type
Experimental
Arm Description
Intranasal administered insulin
Arm Title
Cannabidiol CR
Arm Type
Experimental
Arm Description
Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant.
Arm Title
URB597
Arm Type
Experimental
Arm Description
URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme.
Intervention Type
Drug
Intervention Name(s)
URB597
Intervention Description
10 mg / d for 5 days, orally
Intervention Type
Drug
Intervention Name(s)
intranasal Insulin
Intervention Description
160 IU / d for 5 days, intranasal
Intervention Type
Drug
Intervention Name(s)
Cannabidiol CR
Other Intervention Name(s)
Arvisol
Intervention Description
320 mg / d for 5 days, orally
Primary Outcome Measure Information:
Title
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
Title
Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels)
Time Frame
Seven days
Title
Diagnostics of the cerebrospinal fluid
Time Frame
Seven days
Title
fMRI scan of the brain
Time Frame
Seven days
Secondary Outcome Measure Information:
Title
Regular evaluating of the subject's condition and ability to continue the study by CGI
Time Frame
Seven days
Title
Regular laboratory testing and ECG
Time Frame
Seven days
Title
Scales for the assessment of adverse events (UKU, SCL- 90-R)
Time Frame
Seven days
Title
(Numbers of) SAE and AE
Time Frame
Seven days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
F. Markus Leweke, MD
Phone
+49 621 1703
Ext
2321
Email
leweke@cimh.de
First Name & Middle Initial & Last Name or Official Title & Degree
Cathrin Rohleder, PhD
Phone
+49 621 1703
Ext
2333
Email
rohleder@cimh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Markus Leweke, MD
Organizational Affiliation
Central Institute of Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health
City
Mannheim
State/Province
BW
ZIP/Postal Code
68159
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F. Markus Leweke, MD
Phone
+49 621 1703
Ext
2321
Email
leweke@cimh.de
First Name & Middle Initial & Last Name & Degree
Cathrin Rohleder, PhD
Phone
+49 621 1703
Ext
2333
Email
rohleder@cimh.de
First Name & Middle Initial & Last Name & Degree
J. Malte Bumb, MD
First Name & Middle Initial & Last Name & Degree
Cathrin Rohleder, PhD
First Name & Middle Initial & Last Name & Degree
Till van der List, MD
First Name & Middle Initial & Last Name & Degree
Juliane K. Mueller, MD
First Name & Middle Initial & Last Name & Degree
Frank Enning, MD
12. IPD Sharing Statement
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Evaluation Study of New Compounds With Potential Use in Schizophrenia
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