Evaluation Study of New Compounds With Potential Use in Schizophrenia

NCT00916201 | Withdrawn Phase 1

• 1 other identifier: EICAS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (3)

Intranasal Insulin

EXPERIMENTAL

Intranasal administered insulin

Drug: intranasal Insulin

Cannabidiol CR

EXPERIMENTAL

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

Drug: Cannabidiol CR

URB597

EXPERIMENTAL

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

Drug: URB597

Interventions

URB597 DRUG

10 mg / d for 5 days, orally

URB597

intranasal Insulin DRUG

160 IU / d for 5 days, intranasal

Intranasal Insulin

Cannabidiol CR DRUG

320 mg / d for 5 days, orally

Also known as: Arvisol

Cannabidiol CR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• Max Planck Institute for Metabolism Research: collaborator

Study Sites (1)

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

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

cyclohexyl carbamic acid 3'-carbamoylbiphenyl-3-yl ester

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• F. Markus Leweke, MD

  Central Institute of Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: June 9, 2009
• Study Start: January 31, 2025
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)