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

Central Institute of Mental Health, Mannheim

Status and phase: Withdrawn; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Cannabidiol CR; Drug: intranasal Insulin; Drug: URB597

Study type: Interventional

Funder types: Other

Identifiers

NCT00916201

EICAS

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Intranasal Insulin

Experimental group

Description:

Intranasal administered insulin

Treatment:

Drug: intranasal Insulin

Cannabidiol CR

Experimental group

Description:

Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant.

Treatment:

Drug: Cannabidiol CR

URB597

Experimental group

Description:

URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme.

Treatment:

Drug: URB597