stress in healthy subjects
Conditions
Interventions
Group 1: Alprazolam, 0.5 mg - 0.5 mg- 0.5 mg, capsules, for 5 days
Group 2: Stresam (Etifoxin Hydrochloride), 50 mg- 50 mg - 50 mg, capsules, for 5 days
Group 3: Placebo, capsules, for 5 days
Sponsors
Medizinische Einrichtungen des Bezirks Oberpfalz
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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) 90 bpm - cardiac functional impairments in ECG (except AV-block 1st grade if HR within normal range) - blood pressure: systolic 140 mmHg, diastolic 90 mmHG - body temperature (oral) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective stress level in the Trier Social Stress Test in virtual reality (VR-TSST) on day 5 of treatment woth Etifoxine, Alprazolam or Placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Vigilance/attention; screening, day 1/5 of treatment; reaction time, error rate in the Continuous Performance Test State anxiety during the Trier Social Stress Test in Virtual Reality (VR-TSST); day 5 of treatment; STAI state Cortisol in saliva before (-30 min, -10 min., -1 min) and after VR-TSST (+ 0 min., +10 min., +20 min., +30 min., +45 min.); day 5 of treatment; ELISA Neurosteroid level in serum before (- 4 Std.) and after VR-TSST (+ 1 Std.); day 5 of treatment; ELISA Heart rate, skin conductance and voice parameters before, during and after VR-TSST; day 5 of treatment; Brain Vision Analyzer General mental state during the clinical trial; screening, days 1 to 5 of treatment; PANAS state, STAI state, visual analogue scales Startle reflex at the eye, heart rate, skin conductance, subjective fear/anxiety in the NPU Threat Test; day 1/5 of treatment; Brain Vision Analyzer TSPO expression in thrombocytes; screening, day 1, 4 and 5 of treatment; Western Blot Metabolism of mitochondria in leucocytes; screening, day 1, 4 and 5 of treatment; oxidative phosphorylation, glycolysis: Seahorse XFp, ATP-content: luminescing cell viability assay Expression of microRNA in leucocytes; screening, day 1, 4 and 5 of treatment; miRNeasy kit Oxytocin level in serum; screening, day 1, 4 and 5 of treatment; radioimmunoassay Level of inflammatory cytokines in serum; screening, day 1, 4 and 5 of treatment; ELISA Structural and functional connectivity and connectivity dynamics in the brain; day 4 of treatment; magnetic resonance imaging GABA-concentration in the anterior cingulate cortex (ACC); day 4 of treatment; magnetic resonance spectroscopy | — |
Countries
Germany
Contacts
Public ContactLisa-Marie Bahr
Medizinische Einrichtungen des Bezirks Oberpfalz
Outcome results
None listed