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

Zentralinstitut für Seelische Gesundheit Mannheim0 个研究点开始时间: 2008年2月8日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

Zentralinstitut für Seelische Gesundheit Mannheim