TSPO ligands in the treatment of depression

Trial details

Who runs it

Medizinische Einrichtungen des Bezirks Oberpfalz KU AöR

Trial code

EU 2024-512698-29-00

Record updated

2025. június 26.

Original description

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?Read full original descriptionShow less

TSPO ligands in the treatment of depression: proof-of-concept of efficacy and underlying mechanisms of action

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?

Inclusion: Inpatient treatment in the Bezirksklinikum Regensburg; Willingness to forgo to drive a car or to operate heavy machines; 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; Patients 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 patients have to use a condome during sexual intercourse; 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 instruction; 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.

Exclusion: 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; Positive drug screening (amphetamines, cannabis, opiates, cocaine, Ethylglucuronid, Ethanol, Fentanyl, Pregabalin, Buprenorphine, Methadone); Concurrent participation in another clinical trial according to AMG; 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; 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; Celiac disease, non-celiac-non-wheat allergic-wheat sensitivity (NCHS); Diagnosis of an acute somatic or neurological disease; Heart rate (HR) < 45 or > 110 bpm; 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); 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; Body temperature < 35°C or > 37.5°C; BMI < 19 bzw. > 35; Pregnancy or nursing period; Acute suicidality; Contraindications of the IMP: myasthenia, state of shock, severely impaired liver and/or renal function; Clinically relevant impairments in ECG; Blood pressure: systolic < 90 or > 165 mmHg, diastolic < 50 or > 95 mmHG.

EU CTIS 2024-512698-29-00