Functional role of translocator protein 18 kDa (TSPO) for stress regulationin healthy probands after treatment with anxiolytic compounds
- Conditions
- stress in healthy subjects
- Registration Number
- DRKS00023318
- Lead Sponsor
- Medizinische Einrichtungen des Bezirks Oberpfalz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 60
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
the study
- 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
study
- during pregnancy of the partner the probands have to use a condome
during sexual intercourse
- 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
mmHG
- body temperature (oral) < 35°C or > 37.5°C
- Abnormal laboratory parameters of clinical relevance before study
inclusion:
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method