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

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

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.

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

Study Design

• 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 2020
• Estimated Primary Completion Date: June 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

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

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

• 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

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

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
• Other Study ID Numbers: EICAS
• First Posted: June 9, 2009
• Last Update Posted: August 14, 2019
• Last Verified: August 2019

• 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; Cannabidiol; Anticonvulsants