Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
Trial Parameters
Brief Summary
Study is to evaluate the efficacy and safety of the drug Ranquilon, 1 mg tablets, at a dosage of 6 mg/day compared to the drug Afobazole, 10 mg tablets, at a dosage of 30 mg/day for the treatment of patients with anxiety disorders due to neurasthenia and adjustment disorders.
Eligibility Criteria
Inclusion Criteria: 1. Males and females aged 18 to 70 years; 2. Written informed consent form in accordance with current legislation; 3. Patients with anxiety and established diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2); 4. Anxiety severity on the HARS scale of 18-24 points; 5. Assessment of the severity of suicidal thoughts using the Columbia scale \<3 points; 6. Severity of asthenia on the Multidimensional Fatigue Inventory Scale (MFI-20) greater than 50 points; 7. Total score on the Hamilton Depression Rating Scale (HAMD-17) \< 6; 8. Score on the CGI-s scale of at least 4 points; 9. Negative pregnancy test for women of childbearing potential; 10. Agreement to use effective contraceptive methods throughout the study and for 30 days after its completion (for women of childbearing potential and men); 11. Ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of healt