A Study of the Efficacy and Safety of Ranquilon Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders

Exclusion Criteria

• •1. Known intolerance to the active ingredient and/or excipients in the study drug/placebo of the study drug
• •2. Known presence of lactase deficiency, lactose intolerance, glucose-galactose malabsorption or galactose intolerance
• •3. Patients who require concomitant therapy prohibited in this study (MAO inhibitors, antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), sleeping pills when used on a continuous basis), or have taken these drugs within the last month
• •4. Established or suspected alcohol/drug use at the time of screening or randomization, and/or a history of alcohol, drug or drug dependence
• •5. Presence of cancer, including a history of cancer (with the exception of a cured tumor with sustained remission for more than 5 years)
• •6. Presence of tuberculosis, including a history of tuberculosis
• •7. The presence of HIV, chronic viral hepatitis B/C, syphilis (including a history), or a positive test for HIV, hepatitis B/C, syphilis at screening
• •8. Patients with a diagnosis established on the basis of ICD-10 criteria: other anxiety disorders (F41)
• •9. Schizophrenia, schizoaffective, affective and panic disorders
• •10. Acute psychosis (endogenous-procedural, organic or somatogenic), including history
• •11. Organic lesions of the central nervous system of traumatic and alcoholic genesis
• •12. Postencephalitic syndrome
• •13. Brain tumors, including in the anamnesis
• •14. Degenerative diseases of the central nervous system (CNS), in particular, multiple sclerosis
• •15. Depression, including a history of depression
• •16. Generalized anxiety disorder, including a history
• •17. Suicidal thoughts or ideas; a history of suicide attempts
• •18. Epilepsy, seizures, including a history of seizures
• •19. Diabetes mellitus at the stage of decompensation
• •20. Established diagnosis of chronic kidney disease stage 3A or higher, or glomerular filtration rate (GFR) calculated by the Cockcroft-Gault formula = 59 ml/min/1.73 m2 or less
• •21. Established diagnosis of hepatic failure of any severity, or elevated ALT, AST or total bilirubin, urea \>3 times the upper limit of normal values
• •22. Conditions after major surgical interventions, if less than six months have elapsed since the intervention
• •23. Chronic heart failure New York Heart Association (NYHA) functional class III-IV
• •24. Severe, decompensated, or unstable disease (any disease or condition that threatens the patient's life or worsens the patient's prognosis, or makes it impossible to perform a clinical trial in the patient)
• •25. Pregnant women, women breastfeeding, or women planning to become pregnant during the study and 30 days after study participation ends
• •26. Refusal by the patient to use approved contraception or to completely abstain from sexual intercourse during the entire period of study participation, beginning at Visit 0, and for 30 days after completion of study participation
• •27. Patient's current or planned participation in psychological or psychotherapeutic interventions designed to treat an anxiety disorder during the course of the clinical trial
• •28. Participation in any other clinical trial within 90 days prior to the screening period
• •29. Lack of willingness to cooperate on the part of the patient
• •30. Other reasons that, in the opinion of the investigator, prevent the patient from participating in the study or pose an unreasonable risk to the patient
• •Withdrawal Criteria:
• •1. Patient's desire to stop participating in the study (withdrawal of informed consent) Each patient has the right to stop participating in the study at any time without giving a reason. Withdrawal from the study will not affect the medical care provided to the patient in the future.
• •2. A decision by the research physician that the patient should be excluded is in the patient's own best interest
• •3. Patient refuses to cooperate with the investigator or is undisciplined
• •4. Causes/occurrence of situations during the study that threaten patient safety (e.g., hypersensitivity reactions, SAE, etc.)