Evaluation Study of New Compounds with Potential Use in Schizophrenia

Phase 1

Withdrawn

• Conditions: Schizophrenia
• Interventions: Drug: Cannabidiol CR; Drug: intranasal Insulin; Drug: URB597

• Registration Number: NCT00916201
• Lead Sponsor: Central Institute of Mental Health, Mannheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-09
• Study Start: 2025-01-31
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 86

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cannabidiol CR	Cannabidiol CR	Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant.
Intranasal Insulin	intranasal Insulin	Intranasal administered insulin
URB597	URB597	URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme.

Primary Outcome Measures

Name	Time	Method
Diagnostics of the cerebrospinal fluid	Seven days
fMRI scan of the brain	Seven days
Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels)	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

Secondary Outcome Measures

Name	Time	Method
Regular laboratory testing and ECG	Seven days
Scales for the assessment of adverse events (UKU, SCL- 90-R)	Seven days
Regular evaluating of the subject's condition and ability to continue the study by CGI	Seven days
(Numbers of) SAE and AE	Seven days

Trial Locations

Locations (1)

Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health; 🇩🇪 Mannheim, BW, Germany