Evaluation Study of New Compounds With Potential Use in Schizophrenia

Schizophrenia Clinical Trial

— EICAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00916201
• Other study ID #: EICAS
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2020
• Est. completion date: December 2022

Study information

• Verified date: August 2019
• Source: Central Institute of Mental Health, Mannheim
• Contact: F. Markus Leweke, MD
• Phone: +49 621 1703
• Email: leweke[@]cimh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• URB597
10 mg / d for 5 days, orally
• intranasal Insulin
160 IU / d for 5 days, intranasal
• Cannabidiol CR
320 mg / d for 5 days, orally

Locations

Country	Name	City	State
Germany	Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health	Mannheim	BW

Sponsors (2)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	Max-Planck Institute for Metabolism Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessment with several psychopathological scores for self-assessment and peer evaluation (BPRS, PANSS, SIPS, CGI, MADRS, HAM-A, SCL-90-R)		Seven days
Primary	Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels)		Seven days
Primary	Diagnostics of the cerebrospinal fluid		Seven days
Primary	fMRI scan of the brain		Seven days
Secondary	Regular evaluating of the subject's condition and ability to continue the study by CGI		Seven days
Secondary	Regular laboratory testing and ECG		Seven days
Secondary	Scales for the assessment of adverse events (UKU, SCL- 90-R)		Seven days
Secondary	(Numbers of) SAE and AE		Seven days