Evaluation Study of New Compounds With Potential Use in Schizophrenia

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: URB597
* Drug: intranasal Insulin
* Drug: Cannabidiol CR


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Insulin<br>Intranasal administered insulin | Drug: intranasal Insulin<br>* 160 IU / d for 5 days, intranasal<br>|
| Experimental: Cannabidiol CR<br>Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant. | Drug: Cannabidiol CR<br>* 320 mg / d for 5 days, orally<br>* Other names: Arvisol;|
| Experimental: URB597<br>URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme. | Drug: URB597<br>* 10 mg / d for 5 days, orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia