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 F Markus Leweke, 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 (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.

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by F Markus Leweke, 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 ]
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 ]

Secondary Outcome Measures:

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 ]


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)
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

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

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

ClinicalTrials.gov processed this record on June 23, 2017

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