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Efficacy of Etifoxine in Adults with Adjustment Disorder with Anxiety: A Randomized, Double‑Blind, Placebo‑Controlled Trial

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What is this trial about?

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

This trial investigates the use of the oral medication etifoxine hydrochloride in adults diagnosed with adjustment disorder with anxiety. The aim is to demonstrate that the drug reduces anxiety symptoms more effectively than a matching placebo.

Participants will be randomly assigned to receive either the study drug or placebo for up to twelve weeks, with regular clinic visits to evaluate changes. Anxiety severity will be measured using the HAM-A questionnaire, a list of questions that rates how intense anxiety symptoms are. Overall clinical improvement will be recorded with the CGI scale, where a clinician judges how much the condition has changed. Patients will also provide their own view of improvement on the PGI-I scale, a simple rating of how they feel compared with the start of treatment. General well‑being will be assessed with the WHO-5 questionnaire, which asks about mood and daily life satisfaction.

Safety will be closely observed throughout the study, with any side effects such as liver problems or skin reactions being reported promptly. The trial follows a double‑blind design, meaning neither the participants nor the investigators know which treatment is being given, to ensure unbiased results.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and randomization

    You attend the first study visit after joining the trial. during this visit you complete questionnaires that measure anxiety (the ham‑a scale) and overall clinical impression (the cgi scale). you also receive information about the study procedures.

    Based on the information collected, you are randomly assigned to receive either etifoxine capsules or matching placebo capsules. the assignment is concealed, so neither you nor the study staff know which one you receive.

  2. Step 2

    Start of medication

    On the day after the baseline visit you begin taking the study medication. each dose consists of four hard capsules, each containing 50 mg of etifoxine hydrochloride, for a total of 200 mg per day. if you are assigned to the placebo group, the capsules look identical but contain no active drug.

    The capsules are taken orally, preferably with a glass of water, once each morning.

  3. Step 3

    Daily medication intake

    You continue to take the four capsules every day for the duration of the treatment period. the treatment period lasts for 12 weeks.

  4. Step 4

    Self‑assessment of improvement

    For the first four weeks you complete the patient global impressions of improvement (pgi‑i) questionnaire every 7 days (day 7, day 14, day 21, day 28). after week 4 you complete the same questionnaire every 14 days (day 42, day 56, day 70, day 84). the questionnaire asks you to rate how much your anxiety has improved compared with the start of the study.

  5. Step 5

    Clinic visit at week 4 (visit 3)

    You attend a study visit four weeks after starting the medication. during this visit the researcher records your ham‑a score, cgi score, and any side effects you have experienced. the ham‑a score is used to determine whether your anxiety has improved by at least 30 % compared with baseline.

  6. Step 6

    Clinic visit at week 8 (visit 4)

    You attend a second follow‑up visit eight weeks after starting the medication. the ham‑a score, cgi score, and pgi‑i questionnaire results are recorded again. the study also checks whether you meet the criteria for a responder (improvement of at least 30 % and a cgi‑i rating of 1 or 2).

  7. Step 7

    Clinic visit at week 12 (visit 5)

    You attend the final treatment visit twelve weeks after starting the medication. the ham‑a score, cgi score, and pgi‑i questionnaire are recorded for the last time. the study also determines whether you are in remission (ham‑a score ≤ 7 and cgi‑s rating of 1).

  8. Step 8

    Well‑being assessment at week 16 (visit 6)

    Four weeks after the end of treatment you complete the who‑5 well‑being scale. this questionnaire measures your overall sense of well‑being compared with the start of the study.

  9. Step 9

    Ongoing safety monitoring

    Throughout the entire study you are asked to report any unwanted effects, especially signs of liver problems or skin rash, which are considered events of special interest. all reported events are recorded and evaluated by the study team.

Who can join the trial?

8 criteria

  • Be a man or woman aged between 18 and 70 years.
  • Be an out‑patient who has been diagnosed with adjustment disorder with anxiety (ADWA) according to the official diagnostic guide called DSM‑5‑TR (code 309.24) and who needs treatment.
  • Have a stable but troublesome ADWA that is linked to a difficult situation that has not been resolved at the time you join the study.
  • Score 25 or higher on the Hamilton Anxiety Rating Scale (HAM‑A), a questionnaire that measures how severe your anxiety symptoms are.
  • Score less than 16 on the Montgomery‑Åsberg Depression Rating Scale (MADRS), a questionnaire that measures how severe depression symptoms are.
  • If you are a woman who could become pregnant, you must agree to use one or more acceptable birth control methods for the whole time you are in the study.
  • Be able to read and understand the study documents and the information leaflet, and be willing to sign the consent form. In Czechia, a designated caregiver or support person must also be informed and sign a separate consent form.
  • Be expected to follow the study rules well, especially taking the study medication exactly as instructed (good compliance with the protocol).

Who cannot join the trial?

18 criteria

  • Having any of the following mental health problems: major depressive episode (feeling very down for a long time), thoughts of suicide, a manic or hypomanic episode (very high mood), generalized anxiety, panic disorder, agoraphobia (fear of open places), social phobia, obsessive‑compulsive disorder, post‑traumatic stress disorder, or alcohol abuse/addiction.
  • Receiving ongoing psychotherapy that has not been stable for at least four months before joining the study, or stopping therapy within one month before the study.
  • Being allergic (hypersensitive) to etifoxine or any of its ingredients, having a history of shock, severe liver (hepatic) or kidney (renal) failure, myasthenia (muscle‑weakness disease), severe hepatitis or liver cell damage from previous etifoxine use, or having had severe skin reactions such as DRESS syndrome, Stevens‑Johnson syndrome, or widespread skin peeling (generalized exfoliative dermatitis) after using etifoxine before.
  • Having other medical illnesses or taking other treatments that the doctor believes could make it hard to follow the study rules or affect the results.
  • Having a past history of liver or skin problems that are not compatible with taking part in the study.
  • Having a positive urine pregnancy test (for women).
  • Being under legal guardianship or curatorship (someone else makes medical decisions).
  • Being under court protection or deprived of liberty (incarcerated).
  • Participating in another clinical trial or having taken another trial drug within the last 30 days (or five half‑lives of that drug, whichever is longer).
  • Being so ill right now that you cannot give consent to join the study.
  • Having other psychiatric or neurological disorders such as personality disorders, a history of psychotic disorder, or epilepsy (seizure disorder).
  • Having an organic condition that can cause anxiety, such as a thyroid problem, or having a life‑threatening illness.
  • Having current or past drug abuse or addiction, or being in withdrawal.
  • Being pregnant, breastfeeding, or a woman who could become pregnant and is not using an effective birth‑control method.
  • Using sleep‑inducing or anxiety‑reducing medicines (like benzodiazepines, zolpidem, zopiclone, or herbal remedies) in the month before the study.
  • Taking regular medicines that could change how the study drug is processed, such as carbamazepine, phenytoin, primidone, or rifampicin, during the study.
  • Using any psychotropic medication (antidepressants, antipsychotics, mood stabilizers) or St. John’s wort (hypericum) in the four months before the study.
  • Being treated with beta‑blocker drugs.
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Investigated drugs

Etifoxine is an oral medication given in capsule form. In this study it is being tested as the only treatment for people who have adjustment disorder with anxiety. The goal is to see if taking etifoxine can reduce the feelings of nervousness, worry, and other anxiety symptoms compared with a dummy pill.

What is already known about the treatment

  • Matching placebo capsules

    These are hard capsules taken by mouth that contain no active drug, serving only as a control in the study; they are not a medicine and have no therapeutic use. The capsules look the same as the test drug so participants cannot tell the difference. They are used solely to compare the effects of the real medication against a neutral substance. This helps researchers see whether any improvement is due to the active drug or not.

  • STRESAM 50 mg capsules, hard

    This medication is taken orally as a hard capsule containing 50 mg of etifoxine hydrochloride, usually taken twice a day for a total of 200 mg. Etifoxine is an approved anxiolytic in several countries and is studied in medical literature for its ability to reduce anxiety without strong sedation. It works by supporting the brain’s natural calming chemicals, helping to calm nervous activity and reduce anxiety symptoms. Its pharmacological class is a non‑benzodiazepine anxiolytic, used mainly for anxiety related to adjustment disorders.

Investigated diseases

Adjustment disorder with anxiety - Adjustment disorder with anxiety is a stress‑related condition that begins after a recognizable life change or stressful event. It is marked by excessive worry, nervousness, and physical signs such as restlessness or tension. Symptoms usually start within three months of the trigger and can last up to six months if the stressor is not resolved. The anxiety may interfere with daily activities, sleep, and concentration. As the person adapts to the situation or the stressor lessens, the symptoms typically improve. If the stress continues, the anxiety may become more persistent.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524287-38-00Protocol codeETI242Estimated enrolment412 patientsSponsorBiocodex

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