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

Evaluation of Potential Central Glucoregulatory Compounds to Treat/Ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers.

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: intranasal Insulin; Drug: Cannabidiol CR; Drug: URB597

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • BW
    • Mannheim, BW, Germany, 68159
      • Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Arvisol
Experimental: URB597; URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme.	Drug: URB597; 10 mg / d for 5 days, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical assessment with several psychopathological scores for self-assessment and peer evaluation (BPRS, PANSS, SIPS, CGI, MADRS, HAM-A, SCL-90-R)	Seven days
Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels)	Seven days
Diagnostics of the cerebrospinal fluid	Seven days
fMRI scan of the brain	Seven days

Secondary Outcome Measures

Outcome Measure	Time Frame
Regular evaluating of the subject's condition and ability to continue the study by CGI	Seven days
Regular laboratory testing and ECG	Seven days
Scales for the assessment of adverse events (UKU, SCL- 90-R)	Seven days
(Numbers of) SAE and AE	Seven days

Collaborators and Investigators

• Sponsor: Central Institute of Mental Health, Mannheim
• Collaborators: Max Planck Institute for Metabolism Research
• Investigators: Principal Investigator: F. Markus Leweke, MD, Central Institute of Mental Health

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: June 5, 2009
• First Posted (Estimate): June 9, 2009

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: EICAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No