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TSPO ligands in the treatment of depression
EU CTIS ID: 2024-512698-29-00
What this study is testing
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?
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
- Body temperature < 35°C or > 37.5°C
- BMI < 19 bzw. > 35
- 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)
- 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.
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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.
- Body temperature < 35°C or > 37.5°C
- BMI < 19 bzw. > 35
- 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)
- 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)
- Diagnosis of an acute somatic or neurological disease
- Concurrent participation in another clinical trial according to AMG
- 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) < 45 or > 110 bpm
- Clinically relevant impairments in ECG
- Blood pressure: systolic < 90 or > 165 mmHg, diastolic < 50 or > 95 mmHG
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.