Study of Ranquilon Versus Afobazole for Treating Anxiety Disorders Linked to Neurasthenia and Adjustment Disorders

What this Trial Is About

Researchers are evaluating the efficacy and safety of the drug Ranquilon compared to Afobazole in adults with anxiety disorders caused by neurasthenia and adjustment disorders. This Phase IV, open-label, randomized, multicenter study aims to compare these treatments in patients aged 18 to 70 years who have specific anxiety levels and meet defined diagnostic criteria. Participants will receive either Ranquilon tablets at a dose of 6 mg per day or Afobazole tablets at 30 mg per day for 28 days. The study includes assessments at baseline and on Day 29, with safety and tolerability monitored through various clinical tests and vital signs up to Day 43. The trial evaluates anxiety reduction and other related symptoms using scales like the Hamilton Anxiety Rating Scale and Clinical Global Impression. During the study, participants will undergo multiple evaluations including blood tests, urinalysis, and assessments of anxiety, fatigue, depression, and suicidal thoughts. Researchers will track adverse events and treatment adherence, with the primary outcome measured by the proportion of patients achieving a significant reduction in anxiety by Day 29. The study concludes with safety follow-up to Day 43, ensuring comprehensive monitoring of participants throughout the trial.

Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders