Etifoxine hydrochloride for Major depressive disorder | Bipolar depression

Inclusion criteria

• {"criterion_text":"- Inpatient treatment in the Bezirksklinikum Regensburg"}
• {"criterion_text":"- Willingness to forgo to drive a car or to operate heavy machines"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients with partners in a reproductive age must be willing to use appropriate contraceptives (Pearl-Index < 1%) for the duration of the study"}
• {"criterion_text":"- During pregnancy of the partner the patients have to use a condome during sexual intercourse"}
• {"criterion_text":"- Male and female patients in the age between 18 and 65 years"}
• {"criterion_text":"- Voluntary admission to hospital independent from the trial"}
• {"criterion_text":"- Diagnosis of unipolar (ICD-10: F32, F33) or bipolar depression (ICD-10: F31.3-5)"}
• {"criterion_text":"- HAMD-21 score > 18"}
• {"criterion_text":"- 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 instruction"}
• {"criterion_text":"- Written informed consent after the trial has been comprehensively explained"}
• {"criterion_text":"- Indication for pharmacological treatment independent of the trial"}
• {"criterion_text":"- Willingness to forgo the consumption of alcohol during participation in the study"}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Body temperature < 35°C or > 37.5°C"}
• {"criterion_text":"- BMI < 19 bzw. > 35"}
• {"criterion_text":"- Abnormal laboratory parameters of clinical relevance before study inclusion: Excess of thresholds: GPT, GOT and γ-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)"}
• {"criterion_text":"- Pregnancy or nursing period"}
• {"criterion_text":"- Abuse of alcohol or drugs within the last 12 months before the inclusion screening diagnosed using the M.I.N.I."}
• {"criterion_text":"- Dependence of alcohol or drugs in the medical history diagnosed using the M.I.N.I."}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Galactose intolerance, lack of lactose, glucose-galactose malabsorption"}
• {"criterion_text":"- Celiac disease, non-celiac-non-wheat allergic-wheat sensitivity (NCHS)"}
• {"criterion_text":"- Positive drug screening (amphetamines, cannabis, opiates, cocaine, Ethylglucuronid, Ethanol, Fentanyl, Pregabalin, Buprenorphine, Methadone)"}
• {"criterion_text":"- Diagnosis of an acute somatic or neurological disease"}
• {"criterion_text":"- Concurrent participation in another clinical trial according to AMG"}
• {"criterion_text":"- Acute suicidality"}
• {"criterion_text":"- Contraindications of the IMP: myasthenia, state of shock, severely impaired liver and/or renal function"}
• {"criterion_text":"- Contraindications against the implementation of functional Imaging (pacemaker, metal implants, tattoos in the head/neck area)"}
• {"criterion_text":"- Permanent treatment with 5alpha-reductase-inhibitors, pregabaline or gabapentine over 2 weeks prior to participation in the study"}
• {"criterion_text":"- Heart rate (HR) < 45 or > 110 bpm"}
• {"criterion_text":"- Clinically relevant impairments in ECG"}
• {"criterion_text":"- Blood pressure: systolic < 90 or > 165 mmHg, diastolic < 50 or > 95 mmHG"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"ET50 estimated from serial Hamilton Depression Rating Scale (HAMD-21) scores measured at baseline and days 1,2,3,4,5,6,7,8,15,22,29 after start of treatment."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"HAMD-21 assessed at baseline and days 1,2,3,4,5,6,7,8,15,22,29."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"PHQ-9 assessed at baseline and days 1,2,3,4,5,6,7,8,15,22,29."}
• {"endpoint_text":"- VAS-scores at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment","definition_or_measurement_approach":"Visual Analogue Scale scores assessed at baseline and days 1,2,3,4,5,6,7,8,15,22,29."}
• {"endpoint_text":"- BDI-score at baseline and on days 8, 15, 22 and 29 after start of treatment","definition_or_measurement_approach":"Beck Depression Inventory assessed at baseline and days 8,15,22,29."}
• {"endpoint_text":"- HAM-A score at baseline and on days 8, 15, 22 and 29 after start of treatment","definition_or_measurement_approach":"Hamilton Anxiety Rating Scale assessed at baseline and days 8,15,22,29."}
• {"endpoint_text":"- MADRS score at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment","definition_or_measurement_approach":"MADRS assessed at baseline and days 1,2,3,4,5,6,7,8,15,22,29."}
• {"endpoint_text":"- SSS score at baseline and on days 8, 15, 22 and 29 after start of treatment","definition_or_measurement_approach":"SSS assessed at baseline and days 8,15,22,29."}
• {"endpoint_text":"- C-SSRs score at baseline and on days 8, 15, 22 and 29 after start of treatment","definition_or_measurement_approach":"C-SSRS suicide rating scale assessed at baseline and days 8,15,22,29."}
• {"endpoint_text":"- Adverse events on days 1, 8, 15, 22 and 29 after start of treatment","definition_or_measurement_approach":"Recording of adverse events at days 1,8,15,22,29."}
• {"endpoint_text":"- Neurosteroids in serum (pregnenolone, progesterone, 5α-dihydroprogesterone, allopregnanolone, epipregnanolone, pregnanolone, corticosterone, deoxycorticosterone) at baseline and on day 15 after start of treatment","definition_or_measurement_approach":"Quantification of listed serum neurosteroids at baseline and day 15."}
• {"endpoint_text":"- TSPO expression in thrombocytes at baseline and on day 15 after start of treatment","definition_or_measurement_approach":"Measurement of TSPO expression in platelets at baseline and day 15."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Salivary cortisol measured at awakening, +30 and +60 minutes at baseline and day 15 to compute CAR."}
• {"endpoint_text":"- Cognitive functions assessed with the CANTAB test battery at baseline and on day 15 after start of treatment","definition_or_measurement_approach":"CANTAB neuropsychological battery at baseline and day 15."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"fMRI BOLD amplitude changes during task measured at baseline, day 15 and day 29."}
• {"endpoint_text":"- Representational dissimilarity of emotional stimuli at baseline and on day 15 and 29 after start of treatment","definition_or_measurement_approach":"fMRI/behavioral representational dissimilarity analyses at baseline, day 15 and day 29."}
• {"endpoint_text":"- Functional connectivity and connectivity dynamics at baseline and on day 15 and 29 after start of treatment","definition_or_measurement_approach":"Resting-state/task fMRI connectivity metrics at baseline, day 15 and day 29."}
• {"endpoint_text":"- Alpha diversity (number of species in one habitat) of the microbiome at baseline and on day 15 and 29 after start of treatment","definition_or_measurement_approach":"Microbiome alpha diversity measured at baseline, day 15 and day 29."}
• {"endpoint_text":"- Beta diversity (development of the number of species in one habitat) of the microbiome at baseline and on day 15 and 29 after start of treatment","definition_or_measurement_approach":"Microbiome beta diversity analyses at baseline, day 15 and day 29."}
• {"endpoint_text":"- Odour capacity quantified by the SDI-score at baseline and on day 15 and 29 after start of treatment","definition_or_measurement_approach":"SDI-score olfactory assessment at baseline, day 15 and day 29."}

Methods

• Recruitment of inpatients at Bezirksklinikum Regensburg (inpatient treatment at the study site) — inclusion criterion: Inpatient treatment in the Bezirksklinikum Regensburg; voluntary admission independent from the trial.
• Screening of admitted patients at the single German study site (no other recruitment channels or country-specific approaches are specified in the record).

Germany

Earliest CTIS Part Ii Submission Date

11-03-2024

Latest Decision Or Authorization Date

25-07-2024

Processing Time Days

136

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Medizinische Einrichtungen des Bezirks Oberpfalz KU AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany