Evaluation Study of New Compounds With Potential Use in Schizophrenia

NCT ID: NCT00916201

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-01-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intranasal Insulin

Intranasal administered insulin

Group Type: EXPERIMENTAL

intranasal Insulin

Intervention Type: DRUG

160 IU / d for 5 days, intranasal

Cannabidiol CR

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

Group Type: EXPERIMENTAL

Cannabidiol CR

Intervention Type: DRUG

320 mg / d for 5 days, orally

URB597

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

Group Type: EXPERIMENTAL

URB597

Intervention Type: DRUG

10 mg / d for 5 days, orally

Interventions

URB597

10 mg / d for 5 days, orally

Intervention Type: DRUG

intranasal Insulin

160 IU / d for 5 days, intranasal

Intervention Type: DRUG

Cannabidiol CR

320 mg / d for 5 days, orally

Intervention Type: DRUG

Other Intervention Names

Arvisol

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Max Planck Institute for Metabolism Research

OTHER

Sponsor Role: collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

F Markus Leweke

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

F. Markus Leweke, MD

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health

Locations

Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

EICAS

Identifier Type: -

Identifier Source: org_study_id