NCT00916201撤回1 期
Evaluation of Potential Central Glucoregulatory Compounds to Treat/ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers.
Central Institute of Mental Health, Mannheim1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Diagnostics of the cerebrospinal fluid
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Non-Smoker
- •Body Mass Index between 18 and 40.
排除标准
- •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)
研究组 & 干预措施
Intranasal Insulin
Experimental
Intranasal administered insulin
干预措施: intranasal Insulin (Drug)
Cannabidiol CR
Experimental
Cannabidiol is the main non psychoactive compound of the Cannabis sativa plant.
干预措施: Cannabidiol CR (Drug)
URB597
Experimental
URB597 is a selective inhibitor of the Fatty acid amide hydrolase enzyme.
干预措施: URB597 (Drug)
结局指标
主要结局
Diagnostics of the cerebrospinal fluid
时间窗: Seven days
fMRI scan of the brain
时间窗: Seven days
Laboratory assessment (routine testing, "-omics", genetic analyses, endocannabinoid levels)
时间窗: Seven days
Clinical assessment with several psychopathological scores for self-assessment and peer evaluation (BPRS, PANSS, SIPS, CGI, MADRS, HAM-A, SCL-90-R)
时间窗: Seven days
次要结局
- 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)
研究者
F Markus Leweke
Professor
Central Institute of Mental Health, Mannheim
研究点 (1)
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Evaluation of potential central glucoregulatory compounds to treat/ameliorate the symptoms of schizophrenia: a proof-of-concept study in healthy volunteers - EICASBasic 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: SchizophreniaEUCTR2007-002245-20-DEZentralinstitut für Seelische Gesundheit Mannheim
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