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Study on the Effects of Etifoxine in Treating Depression in Patients with Unipolar or Bipolar Disorder

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called etifoxine hydrochloride in treating depression, specifically in individuals with unipolar or bipolar depressive disorder. The study aims to understand how this medication, when added to the usual treatment, affects the symptoms of depression. Participants will receive either the medication or a placebo, which looks the same but does not contain the active ingredient.

The study will last for a period of 14 days, during which participants will take the medication in the form of a hard capsule by mouth. The effects of the treatment will be monitored by assessing the severity of depression symptoms using a tool called the Hamilton Scale for Depression (HAMD-21). This assessment will be conducted several times throughout the study to track any changes in symptoms.

The purpose of this study is to determine if adding etifoxine hydrochloride to the usual treatment can speed up the improvement of depression symptoms compared to adding a placebo. Participants will be closely monitored for any changes in their condition and any side effects that may occur during the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is required to provide written informed consent after the trial has been comprehensively explained.

    The patient must be an inpatient at the specified clinic and meet the inclusion criteria, such as age between 18 and 65 years and a diagnosis of unipolar or bipolar depression.

  2. Step 2

    Baseline assessment

    Initial assessments are conducted to establish baseline scores for various scales, including the Hamilton Scale for Depression (HAMD-21), PHQ-9, and others.

    Blood samples may be taken to measure neurosteroids and TSPO expression, and saliva samples for cortisol levels.

  3. Step 3

    Treatment initiation

    The patient begins treatment with the TSPO ligand etifoxine or a placebo, in addition to their usual treatment.

    The medication is administered orally in the form of a hard capsule.

  4. Step 4

    Treatment period

    The treatment lasts for 14 days, during which the patient continues to take the medication as prescribed.

    Regular assessments are conducted on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22, and 29 to monitor changes in depression symptoms and other health indicators.

  5. Step 5

    Follow-up assessments

    Additional assessments are performed on days 8, 15, 22, and 29 to evaluate the patient's progress and any side effects.

    These assessments include various scales and tests to measure cognitive functions, emotional responses, and other health parameters.

  6. Step 6

    End of study participation

    The patient's participation in the study concludes after the final assessments on day 29.

    The results from the study will contribute to understanding the efficacy of the treatment.

Who can join the trial?

13 criteria

  • Must be receiving treatment as an inpatient at Bezirksklinikum Regensburg.
  • Must agree not to drive a car or operate heavy machinery during the study.
  • Women of Childbearing Potential (WOCBP) need a negative pregnancy test and must agree to use reliable birth control during the study. This includes methods like birth control pills, hormone-releasing devices, or surgical procedures.
  • Patients with partners who can have children must agree to use effective birth control during the study.
  • If the partner is pregnant, patients must use a condom during sexual intercourse.
  • Must be between 18 and 65 years old.
  • Must have voluntarily admitted themselves to the hospital, not just for the trial.
  • Must have a diagnosis of either unipolar depression or bipolar depression. These are types of mood disorders.
  • Must have a score greater than 18 on the HAMD-21, which is a scale used to measure the level of depression.
  • Must be able to understand the nature, meaning, and consequences of participating in the clinical trial.
  • Must provide written informed consent after the study has been fully explained.
  • Must need medication treatment, regardless of the trial.
  • Must agree not to consume alcohol during the study.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with **unipolar** or **bipolar depressive disorder** cannot participate. These are types of depression, with unipolar being a consistent low mood and bipolar involving mood swings.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population, which means groups that may need special protection, are not eligible.
  • Patients who do not meet other specific criteria set by the study, which are not detailed here, cannot participate.
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Investigated drugs

Etifoxine is a medication being studied for its potential to help treat depression. It is used in addition to the usual treatment for depression to see if it can improve symptoms more quickly. The study aims to find out if adding etifoxine can speed up the response to treatment in people with unipolar or bipolar depressive disorder.

What is already known about the treatment

Etifoxine – Etifoxine is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating unipolar and bipolar depressive disorders. The main therapeutic indication is to alleviate symptoms of depression. At the molecular level, etifoxine acts as a TSPO ligand, which is believed to modulate the production of neurosteroids that have calming effects on the brain. It is classified pharmacologically as an anxiolytic agent.

Investigated diseases

  • Unipolar Depressive Disorder

    This is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It affects a person's thoughts, behavior, and overall well-being. Symptoms can include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The disorder can vary in severity and duration, with some individuals experiencing recurrent episodes. It is distinct from bipolar disorder as it does not involve the manic episodes seen in bipolar disorder.

  • Bipolar Depressive Disorder

    This condition is part of bipolar disorder, which involves mood swings that include emotional highs (mania or hypomania) and lows (depression). During depressive episodes, individuals may experience symptoms similar to unipolar depression, such as sadness, loss of energy, and disinterest in daily activities. These depressive episodes can alternate with periods of mania, where the person may feel overly energetic, euphoric, or irritable. The frequency and intensity of these mood swings can vary widely among individuals.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512698-29-00Protocol codeTSPOC5FOR2022Estimated enrolment50 patientsSponsorMedizinische Einrichtungen des Bezirks Oberpfalz KU AöR

sourced from the EU Clinical Trials Register and site verification

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