A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Etifoxine Monotherapy in The Treatment of Adjustment Disorder with Anxiety (ADWA)

Condition studied

Treatment of adjustment disorder with anxiety (ADWA).

Investigational medicinal product(s)

Eligibility

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”).

Endpoint detail

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., 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., 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