Schizophrenia
Conditions
Keywords
schizophrenia
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.
Interventions
DRUGURB597
10 mg / d for 5 days, orally
DRUGintranasal Insulin
160 IU / d for 5 days, intranasal
DRUGCannabidiol CR
320 mg / d for 5 days, orally
Sponsors
Max Planck Institute for Metabolism Research
Central Institute of Mental Health, Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fMRI scan of the brain | Seven days |
| 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 |
Secondary
| 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 |
Countries
Germany
Outcome results
None listed