DRKS00023318已完成1 期
Functional role of translocator protein 18 kDa (TSPO) for stress regulationin healthy probands after treatment with anxiolytic compounds - Functional role of TSPO in human stress regulation
Medizinische Einrichtungen des Bezirks Oberpfalz0 个研究点目标入组 60 人开始时间: 2020年10月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •Male probands in the age between 18 and 55 years
- •- Ability to conceive nature, meaning and consequences of participation in the clinical trial and to understand and implement the explanations concerning the study as well as the instructions of the principal investigator
- •- After the course of the study has been explained completely and extensively and probands gave their informed consent in written form they are included in the study.
- •- appropriate personal maturity
- •- willingness to forgo the consumption of alcohol during participation in
- •- willingness to forgo to drive a car or to operate heavy machines
- •- probands with partners in a reproductive age must be willing to use
- •appropriate contraceptives (Pearl-Index < 1%) for the duration of the
- •- during pregnancy of the partner the probands have to use a condome
- •during sexual intercourse
排除标准
- •- Female gender
- •- Actual diagnosis of a mental disorder like affective disorders,
- •schizophrenia, addiction disorders according to ICD-10, or presence of
- •another psychic main diagnosis in accord with ICD-10 diagnosed using
- •the M.I.N.I.
- •- Diagnosis of a somatic or neurological disease
- •- contraindications of the study medication: myasthenia, state of shock,
- •severe respiration insufficiency, sleep apnoea syndrome, severely
- •impaired liver and/or renal function, acute intoxication by alcohol or
- •other CNS active substances
- •- heart rate (HR) < 50 or > 90 bpm
- •- cardiac functional impairments in ECG (except AV-block 1st grade if HR
- •within normal range)
- •- blood pressure: systolic < 90 or > 140 mmHg, diastolic < 50 or > 90
- •- body temperature (oral) < 35°C or > 37.5°C
- •- Abnormal laboratory parameters of clinical relevance before study
- •Excess of thresholds: GPT above 10 %, GOT above 20 %, bilirubin above
- •20 %, creatinine up to 0,1 mg/dL
- •excess of the normal range more than twice as much of the upper
- •standard or underrun of more than half of the lower standard for the other laboratory parameters (erythrocytes, leucocytes, thrombocytes,
- •hemoglobin, hematocrit, MCH, MCHC, MCV, lymphocytes, monocytes,
- •eosinophils, basophils, neutrophils, natrium, potassium, calcium, iron,
- •transferrin, ferritin, urea, uric acid, sober glucose, overall protein,
- •triglycerides, cholesterol, HDL, LDL, ?-GT, amylase, lipase, C-reactive
- •protein (CRP), TSH, free Trijodthyronin (fT3), free Thyroxin (fT4), Quick,
- •PTT, HbA1c)
- •- insufficient knowledge of German language
- •- regularly intake of medication
- •- abuse of alcohol or drugs within the last 12 months before the
- •inclusion screening diagnosed using the M.I.N.I.
- •- dependence of alcohol or drugs in the medical history diagnosed using
- •the M.I.N.I.
- •- probands that contain an increased risk of suicidality, resp.
- •endangerment of self and others in the investigator's view
- •- Known allergy or hypersensitivity against Etifoxine Hydrochloride,
- •Alprazolam or one of the other components (talc, docusate sodium,
- •sodium benzoate, preagglutinated starch, microcrystalline cellulose,
- •Lactose Monohydrate, Magnesium stearate (Ph. Eur.), highly-dispersed
- •silicon dioxide, titanium dioxide, Indigotine, Erythrosin)
- •- galactose intolerance, lack of lactose, glucose-galactose malabsorption
- •- Treatment with psychotropic medication within the last six months
- •- Contraindications against the implementation of functional imaging
- •(pacemaker, metal implants, tattoos in the head/neck area)
- •- Smokers (> 5 cigarettes/day)
- •- positive drug screening (amphetamines, benzodiazepines, cannabis,
- •opiates, cocaine, Ethylglucuronid, Ethanol, Fentanyl, Pregabalin,
- •Buprenorphine, Methadone)
- •- previous participation in a study using the TSST
- •- concurrent participation in another study according to AMG
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