Evaluation of potential central glucoregulatory compounds to treat/ameliorate the symptoms of schizophrenia: a proof-of-concept study in healthy volunteers - EICAS

• Conditions: Basic ressearch on schizophrenia. This is a proof-of-concept trial. The hypothesis is that substances that regulate the central glucose utilisation might ameliorate symptoms of schizophrenic psychosis. In this clinical trial healthy volunteers will take one of these substances or placebo for seven days and will extensively tested for within and after the administration.; MedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2007-002245-20-DE
• Lead Sponsor: Zentralinstitut für Seelische Gesundheit Mannheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 females and males in fertile age, reliable contraception during interventional phase, which means contraception’s pearl-index is < 1 (birth control pill, intrauterine device, 3-months-injection, subcutaneus hormone releasing implant, a vaginal ring or a condom only in combinations with a portio cap.
• Exclusion of pregnancy (through negative ß-HCG test) or lactation phase in female subjects at the time of screening
• Non-Smoker, defined as less smoking no cigarettes for more than 6 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Lack of capacity
• 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
• Severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures assessed at the time of the screening by the subject’s history, clinical examination and laboratory testing, at the discretion of the investigator
• Acute or chronic infection with either authorised by the subject hepatitis B or C in a serological test
• Clinical relevant QTc-elongation in a current ECG
• Intake of interfering medication, at the discretion of the investigator
• 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)
• Consumption of any illegal drugs (except cannabis in history, see above)
• Subjects are either known participants at other interventional clinical trials interfering with this study or they finished their participation at another interventional clinical trial less than six months before
• Contraindications based on the SPC or the investigator’s brochure
• Dependence or working relationship with the Principal/Coordinating Investigator
• Placement in an institution due to judicial or official directive

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This clinical trial compares in an explorative way the psychometric and molecular effects of the glucoregulators Exenatide and intranasal Insulin, the endocannabinoid modulator Cannabidiol and placebo in healthy volunteers. Main objectives are the changes in the CSF profiles and the changes in the FDG-PET before and after the administration of the IMPs.<br><br>;Secondary Objective: Changes in the neuropsychological performance, startle response, laboratory finding in blood and CSF, EEG, BDII, clinical data and ppsychopathology scales before, partly within and after the administration of the IMPs.<br>;Primary end point(s): Changes between the CSF profile and the FDG-PET brain scans in male participants before and after the administration othe different IMPs and placebos.