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

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 health-related information), and comply with the procedures outlined in the study protocol.
• •1. Known intolerance to the active and/or excipient substances contained in the study drugs;
• •2. Known lactase deficiency, lactose intolerance, glucose-galactose malabsorption, or galactose intolerance;
• •3. Patients requiring prohibited concomitant therapy within this study (MAO inhibitors, antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), hypnotics when used on a regular basis), or who have taken these medications within the last month;
• •4. Established or suspected alcohol/narcotic substance use at the time of screening or randomization, and/or a history of alcohol, narcotic, or drug dependence;
• •5. Presence of oncological diseases, including in history (except for cured tumors with stable remission for more than 5 years);
• •6. Tuberculosis, including in history;
• •7. Presence of HIV, chronic viral hepatitis B/C, syphilis (including past history), or a positive test for HIV, hepatitis B/C, or syphilis at screening;
• •8. Patients with a diagnosis of other anxiety disorders (F41) established based on ICD-10 criteria;
• •9. Schizophrenia, schizoaffective disorders, affective disorders, and panic disorders;
• •10. Acute psychosis (endogenous-processual, organic, or somatogenic), including in history;
• •11. Organic lesions of the central nervous system of traumatic and alcoholic origin;
• •12. Post-encephalitic syndrome;
• •13. History of brain tumors (including past diagnoses);
• •14. Degenerative diseases of the central nervous system (CNS), particularly multiple sclerosis;
• •15. History of depression (including past episodes);
• •16. Suicide attempts in history;
• •17. Generalized anxiety disorder, including in history;
• •18. History of epilepsy and seizures (including past episodes);
• •19. Decompensated diabetes mellitus;
• •20. Established diagnosis of chronic kidney disease stage 3A and above, or estimated glomerular filtration rate (eGFR) calculated by the Cockcroft-Gault formula ≤ 59 ml/min/1.73 m²;
• •21. Established diagnosis of liver failure of any severity, or elevated levels of ALT, AST or total bilirubin \>3 times the upper limit of normal according to laboratory standards;
• •22. History of major surgical interventions within six months prior to screening;
• •23. Chronic heart failure III-IV functional class according to the New York Heart Association (NYHA) classification;
• •24. Severe, decompensated, or unstable diseases (any diseases or conditions that poses a life-threatening risk to the patient, worsens the patient's prognosis, or makes participation in the clinical study impossible);
• •25. Pregnant women, breastfeeding women, or women planning to become pregnant during the study or within 30 days after participation ends;
• •26. Refusal by the patient to use permitted methods of contraception or to completely abstain from sexual contact throughout the entire period of participation in the study starting from Visit 0 and for 30 days after completion of participation;
• •27. Current participation or planned participation by the patient in psychological or psychotherapeutic activities aimed at treating anxiety disorder during the clinical trial period;
• •28. Participation in any other clinical trial within 90 days prior to the start of the screening period;
• •29. Lack of patient cooperation;
• •30. Other reasons, at the investigator's discretion, that may hinder the patient's participation in the study or pose unjustified risk to the patient.