2025-524287-38-00RecruitingPhase 3
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Etifoxine Monotherapy in The Treatment of Adjustment Disorder with Anxiety (ADWA)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Biocodex
- Enrollment
- 412
- Locations
- 46
- Primary Endpoint
- To match the endpoint, patients need to: • either have improved by ≥ 30% their HAM-A total score from baseline AND have a Global Improvement score on CGI scale (CGI-I) ≤ 2 (“Very much improved” or “Much improved”) • either be in remission by having a HAM-A total score ≤ 7 AND Severity of Illness on CGI (CGI-S) = 1 (“Normal, not at all ill”).
Study Overview
Brief Summary
To demonstrate in comparison to placebo the efficacy of etifoxine on manifestations of anxiety
Study Design
- Allocation
- Na
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, between 18 and 70 years old.
- •Out-patient being diagnosed with an ADWA according to DSM-5-TR criteria (309.24) and requiring treatment.
- •Suffering from a stable and troublesome ADWA related to a challenging situation not resolved at the time of the study inclusion.
- •Score ≥ 25 on the Hamilton Anxiety Rating Scale (HAM-A)
- •Score < 16 on the Montgomery-Asberg Depression Rating Scale (MADRS)
- •For women of childbearing potential: willing to use one or more acceptable birth control method throughout the study participation
- •Able to properly read, understand the study documents and the information leaflet, and sign consent form. In Czechia only, a designed caregiver/support person will be appropriately informed and will sign a dedicated informed consent form, (via a separate ICF).
- •Presumable good compliance with the protocol, in particular with taking the treatment.
Exclusion Criteria
- •Concomitant presence of any of the following psychiatric conditions, either known or identified through the MINI interview: • Major depressive episode; • Risk of suicide; • Hypomanic or manic episode; • Generalized anxiety; • Panic disorder; • Agoraphobia; •Social phobia; • Obsessive-compulsive disorders; •Post-traumatic stress disorder; •Alcohol abuse or addiction
- •Patient having an ongoing psychotherapy not stable for ≥4 months before enrolment or stopped in the month before the study
- •Contraindication to etifoxine according to its SmPC: • Hypersensitivity to the active substance or to any of the excipients; • Shock; • Severe hepatic and / or renal insufficiency; • Myasthenia; • Patients who have had severe hepatitis or cytolytic hepatitis during previous treatment with etifoxine; • Patients who have experienced severe dermatological reactions, including DRESS syndrome, Stevens Johnson syndrome (SJS) and generalized exfoliative dermatitis during previous etifoxine treatment.
- •Other medical conditions or comorbidities, treatment, which in the opinion of the Investigator, would interfere with study compliance or data interpretation
- •History of biological or clinical abnormalities, particularly of hepatic or dermatological origin that are not compatible with participation in the study according to the investigator
- •For women, positive urinary pregnancy test
- •Patient under guardianship or curatorship
- •Patient under the protection of the Court or deprived of liberty
- •Patient participating in another interventional clinical trial or within the last 30 days or 5 half-lives of the study investigational treatment, whichever is longer, or in follow-up of another clinical study
- •Patient whose current state of health does not allow him/her to give consent
- •Other psychiatric or neurologic disorders including personality disorders, history of psychotic disorder and history of epilepsy
- •Organic disorder, physiologically source of anxiety (e.g., thyroid condition) or life-threatening
- •Known or suspected drug abuse or drug addiction, withdrawal ongoing
- •Pregnant or breastfeeding women, sexually active women of child-bearing potential without effective method of contraception
- •Any intake of hypnotic or anxiolytic treatment (benzodiazepines, zolpidem, zopiclone or phytotherapy), the month before the study
- •Regular treatment likely to interfere with the metabolism of the study treatments (carbamazepine, phenytoin, primidone, rifampicin) during the study
- •Intake of a psychotropic drug (antidepressant, neuroleptic, mood stabilizer), including hypericum, during the four months preceding the study
- •Patients treated by beta-blocker drugs
Arms & Interventions
STRESAM 50 mg capsules, hard
Test
Intervention: STRESAM 50 mg capsules, hard (Drug)
Matching placebo capsules
Placebo
Intervention: Matching placebo capsules (Drug)
Outcomes
Primary Outcomes
To match the endpoint, patients need to: • either have improved by ≥ 30% their HAM-A total score from baseline AND have a Global Improvement score on CGI scale (CGI-I) ≤ 2 (“Very much improved” or “Much improved”) • either be in remission by having a HAM-A total score ≤ 7 AND Severity of Illness on CGI (CGI-S) = 1 (“Normal, not at all ill”).
To match the endpoint, patients need to: • either have improved by ≥ 30% their HAM-A total score from baseline AND have a Global Improvement score on CGI scale (CGI-I) ≤ 2 (“Very much improved” or “Much improved”) • either be in remission by having a HAM-A total score ≤ 7 AND Severity of Illness on CGI (CGI-S) = 1 (“Normal, not at all ill”).
Secondary Outcomes
- core of Well-being (scale WHO-5): Evaluation of well-being improvement after 4 weeks (V3), 8 weeks (V4), 12 weeks (V5) and 16 weeks (V6) of treatment as compared to baseline.
- Frequency and nature of adverse events in each treatment groups.
- HAM-A total score after 4 weeks (V3), 8 weeks (V4) and 12 weeks (V5) of treatment, expressed as change from baseline.
- The percentage of responder patients matching the composite criteria defined in the primary end point, evaluated after 8 weeks (V4) and 12 weeks (V5) of treatment.
- The percentage of patients with a HAM-A total score ≤ 7 points after 4 weeks (V3), 8 weeks (V4) and 12 weeks (V5) of treatment
- Autoevaluation scale (Patient Global Impressions scale of improvement (PGI-I) evaluated every 7 days for the first 4 weeks of treatment (D7, D14, D21 and D28), and every 14 days for the following 8 weeks of treatment (D42, D56, D70 and D84). PGI-I is a Patient Global Impression scale based on improvement compared to baseline.
- Hepatic adverse events will be considered of “special interest”. Any possible liver disorder will be closely monitored and promptly reported to sponsor.
- Skin rash will also be considered as AE of “special interest”, closely monitored, and promptly reported to sponsor.
- Relapse of anxiety symptoms, rebound effect
Investigators
Laurent CHANCHARME
Scientific
Biocodex
Study Sites (46)
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