Differential effects of TSPO ligands on the functional connectivity and metabolism in the human brain during fear and anxiety
- Conditions
- F40Phobic anxiety disorders
- Registration Number
- DRKS00020267
- Lead Sponsor
- medbo, Medizinische Einrichtungen des Bezirks Oberpfalz – KU (Anstalt des öffentlichen Rechts)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 36
Ability to understand the nature, significance, and implications of participation in the trial, and to understand and implement the trial protocol explanations and investigator's instructions
- After the study procedure has been fully and thoroughly explained and the volunteers have given their informed consent in writing, they will be included in the study.
- Adequate personal maturity
- Willingness to abstain from alcohol consumption during the duration of study participation
- Willingness to refrain from driving a motor vehicle or operating heavy machinery for the duration of the study participation
- subjects with partners of reproductive age must be prepared to use appropriate contraceptive methods for the duration of the study (i.e. contraceptive methods with a Pearl index < 1%)
- If the partner is pregnant, the test persons must use a condom during sexual intercourse, since it is unclear whether active ingredients of the study medication can be transferred to the fetus through coitus
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- Female sex
- Current diagnosis of a mental disorder, such as affective disorders, schizophrenia, addiction, or presence of another major mental disorder according to ICD-10 diagnosed with the M.I.N.I
- Diagnosis of an acute neurological or somatic disease
- Contraindications of the study medication: myasthenia, shock, severe respiratory failure, sleep apnea syndrome, severe liver/kidney dysfunction, acute intoxication by alcohol or other CNS-active substances
- Heart rate (HR) < 50 or > 90 bpm
- Cardiac function limitations in ECG (except: 1st degree AV block if HR is in 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
- Limit crossings GPT over 10 %, GOT over 20 %, bilirubin over 20 %, creatinine up to 0.1 mg/dL
- Exceeding the normal range by more than twice the upper standard value or falling below the lower standard value by more than half of the lower standard value for the other laboratory parameters (erythrocytes, leucocytes, thrombocytes, hemoglobin, hematocrit, MCH, MCHC, MCV, lymphocytes, monocytes, eosinophils, basophils, neutrophils, sodium, potassium, Calcium, iron, transferrin, ferritin, urea, uric acid, fasting glucose, total protein, triglycerides, cholesterol, HDL, LDL, ?-GT, amylase, lipase, C-reactive protein (CRP), TSH, free triiodothyronine (fT3), free thyroxine (fT4), Quick, PTT, HbA1c)
- Insufficient knowledge of German
- Regular intake of medication
- Alcohol or drug abuse in the last twelve months before inclusion screening recorded with the M.I.N.I.
- Alcohol or drug addiction in the medical history recorded with the M.I.N.I
- Subjects who, in the opinion of the investigator, have an increased risk of suicidal behaviour, self-endangerment or exposure to others
- Known allergy or hypersensitivity to etifoxin hydrochloride, alprazolam or any of the other ingredients (talc, docusate sodium, sodium benzoate, pregelatinized starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate (Ph. Eur.), highly dispersed silica, titanium dioxide, indigotine, erythrosine)
- Galactose intolerance, lactose deficiency, glucose-galactose maladaptation
- Treatment with psychotropic medication in the last six months
- Contraindications against MR imaging (pacemakers, metal implants, tattoos in the head and neck area)
- Smoker (> 5 cigarettes / day)
- Positive drug screening for the following substances: amphetamines, benzodiazepines, cannabis, opiates, cocaine, ethylglucuronide, ethanol, fentanyl, pregabalin, buprenorphine, methadone
- Participation in a study on fear/fear paradigm in the past
- Simultaneous participation in another clinical study according to AMG
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Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective level of fear and anxiety in a emotional paradigm
- Secondary Outcome Measures
Name Time Method 1. Vigilance / Attention<br>2. State-anxiety in the course of the emotional paradigm <br>3. Endocrine parameters during the emotional paradigm during MRI <br>4. Physiological parameters of the stress response within the framework of the emotional paradigm <br>5. Structural and functional connectivity and connectivity Dynamics in the MRI<br>6. Intra- and subcortical inhibition determined by paired pulse TMS <br>7. General mental state of the subjects in the course of the clinical trial <br>8. Metabolic parameters in the brain <br>9. Microbiome composition before and after treatment<br>10. Effects on genome transcription/predictability by polymorphisms