Unipolar/bipolar depressive disorder
Conditions
Interventions
Trade Name: Stresam
Product Name: Etifoxine
Product Code: 7560/2006/01-02
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: O
Sponsors
Medizinische Einrichtungen des Berzirks Oberpfalz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Inpatient treatment in the Bezirksklinikum Regensburg - Male and female patients in the age between 18 and 65 years - voluntary admission to hospital independent from the trial - diagnosis of unipolar (ICD-10: F32, F33) or bipolar depression (ICD-10: F31.3-5) - HAMD-21 score > 18 - 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 - written informed consent after the trial has been comprehensively explained - indication for pharmacological treatment independent of the trial - willingness to forgo the consumption of alcohol during participation in the study - Women of Childbearing Potential (WOCBP) need a negative pregnancy test (serum ß-hCG = serum human chorionic gonadotropin) at inclusion and have to be willing to use reliable contraception during the study (eg. oral contraceptives, hormone containing intrauterine coils, dermal or injectable contraceptives with longterm effects, tubal ligation). WOCBP are defined as women after menarche, which are not post-menopausal (at least 12 months no menstruation) und which did not undergo a documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy. - willingness to forgo to drive a car or to operate heavy machines - patients with partners in a reproductive age must be willing to use appropriate contraceptives (Pearl-Index =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - diagnosis of a comorbid mental disorder like schizophrenia, addiction disorders according to ICD-10, or presence of another psychiatric main diagnosis in accordance with ICD-11 diagnosed using the M.I.N.I. - Diagnosis of a somatic or neurological disease - acute suicidality - contraindications of the IMP: myasthenia, state of shock, severely impaired liver and/or renal function - Contraindications against the implementation of functional Imaging (pacemaker, metal implants, tattoos in the head/neck area) - permanent treatment with 5alpha-reductase-inhibitors, pregabaline or gabapentine over 2 weeks prior to participation in the study - heart rate (HR) 110 bpm - clinically relevant impairments in ECG - blood pressure: systolic 165 mmHg, diastolic 95 mmHG - body temperature 37.5°C - BMI 35 - Abnormal laboratory parameters of clinical relevance before study inclusion: Excess of thresholds: GPT, GOT and ?-GT above 20 %, creatinine up to 0,2 mg/dL above age-adapted threshold; 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, transferrin, ferritin, urea, uric acid, sober glucose, overall protein, triglycerides, cholesterol, HDL, LDL, C-reactive protein (CRP), bilirubin, TSH, free Trijodthyronin (fT3), free Thyroxin (fT4), Quick, PTT, HbA1c) - pregnancy or nursing period - 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. - Known allergy or hypersensitivity against Etifoxine Hydrochloride 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 - celiac disease, non-celiac-non-wheat allergic-wheat sensitivity (NCHS) - positive drug screening (amphetamines, cannabis, opiates, cocaine, Ethylglucuronid, Ethanol, Fentanyl, Pregabalin, Buprenorphine, Methadone) - concurrent participation in another clinical trial according to AMG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary goal of the study is to investigate the effects of add-on treatment with the TSPO ligand etifoxine in addition to TAU on clinical symptoms in patients suffering from unipolar/bipolar depressive disorder. Clinical symptoms will be assessed by the grade of depression using the Hamilton Scale for Depression (HAMD-21) several times up to day 15 of treatment. Does add-on treatment with the TSPO ligand etifoxine for 14 days accelerate (reduction of ET50) the response compared to add-on treatment with placebo in addition to TAU?;Secondary Objective: Does add-on treatment with the TSPO ligand etifoxine in depressive patients compared to add-on treatment with placebo in addition to TAU lead to: - an increased treatment response (increase of Emax parameter)? - a reduction of the HAM-D score on day 15? - altered synthesis of neurosteroids, TSPO Expression and/or acitivty of the HPA axis? - altered cognitive functions like memory or emotional processing assessed by a neuropsychological test battery? - changes of functional neuronal networks and cognitive functions assessed using functional magnetic resonance imaging (fMRI) by using resting-state measurements and task-based paradigms? - changes of microbiome composition? - changes of odour capacity? - does cessation of intake of the TSPO ligand lead to a relapse or withdrawal symptoms? ;Primary end point(s): ET50 estimated based on the HAMD-21 scores assessed at the baseline and days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment;Timepoint(s) of evaluation of this end point: A total number of 50 data sets has been obtained. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - HAMD-21 score at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment - PHQ-9 score at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment - VAS-scores at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment - BDI-score at baseline and on days 8, 15, 22 and 29 after start of treatment - HAM-A score at baseline and on days 8, 15, 22 and 29 after start of treatment - MADRS score at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment - SSS score at baseline and on days 8, 15, 22 and 29 after start of treatment - C-SSRs score at baseline and on days 8, 15, 22 and 29 after start of treatment - Adverse events on days 1, 8, 15, 22 and 29 after start of treatment - neurosteroids in serum (pregnenolone, progesterone, 5a-dihydroprogesterone, allopregnanolone, epipregnanolone, pregnanolone, corticosterone, deoxycorticosterone) at baseline and on day 15 after start of treatment - TSPO expression in thrombocytes at baseline and on day 15 after start of treatment - Cortisol Awakening Response (CAR) at baseline and on day 15 after start of treatment measured in saliva directly as well as 30 and 60 minutes after awakening - cognitive functions assessed with the CANTAB test battery ähigkeiten erfasst mit der CANTAB-Testbatterie at baseline and on day 15 after start of treatment - amplitude changes of the blood oxygenation level in fMRI signal (BOLD) during a learning task at baseline and on day 15 and 29 after start of treatment - representational dissimilarity of emotional stimuli at baseline and on day 15 and 29 after start of treatment - functional connectivity and connectivity dynamics at baseline and on day 15 and 29 after start of treatment - alpha diversity (number of species in one habitat) of the microbiome at baseline and on day 15 and 29 after start of treatment - beta diversity (development of the | — |
Countries
Germany
Contacts
Public ContactKlinik für Psychiatrie
Medizinische Einrichtungen des Bezirks Oberpfalz
Outcome results
None listed