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

Inclusion Criteria41

• Males and females aged 18 to 70 years;
• Written informed consent form in accordance with current legislation;
• Patients with anxiety and established diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2);
• Anxiety severity on the HARS scale of 18-24 points;
• Assessment of the severity of suicidal thoughts using the Columbia scale \<3 points;
• Severity of asthenia on the Multidimensional Fatigue Inventory Scale (MFI-20) greater than 50 points;
• Total score on the Hamilton Depression Rating Scale (HAMD-17) \< 6;
• Score on the CGI-s scale of at least 4 points;
• Negative pregnancy test for women of childbearing potential;
• Agreement to use effective contraceptive methods throughout the study and for 30 days after its completion (for women of childbearing potential and men);
• 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.
• Known intolerance to the active and/or excipient substances contained in the study drugs;
• Known lactase deficiency, lactose intolerance, glucose-galactose malabsorption, or galactose intolerance;
• 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;
• Established or suspected alcohol/narcotic substance use at the time of screening or randomization, and/or a history of alcohol, narcotic, or drug dependence;
• Presence of oncological diseases, including in history (except for cured tumors with stable remission for more than 5 years);
• Tuberculosis, including in history;
• 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;
• Patients with a diagnosis of other anxiety disorders (F41) established based on ICD-10 criteria;
• Schizophrenia, schizoaffective disorders, affective disorders, and panic disorders;
• Acute psychosis (endogenous-processual, organic, or somatogenic), including in history;
• Organic lesions of the central nervous system of traumatic and alcoholic origin;
• Post-encephalitic syndrome;
• History of brain tumors (including past diagnoses);
• Degenerative diseases of the central nervous system (CNS), particularly multiple sclerosis;
• History of depression (including past episodes);
• Suicide attempts in history;
• Generalized anxiety disorder, including in history;
• History of epilepsy and seizures (including past episodes);
• Decompensated diabetes mellitus;
• 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;
• 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;
• History of major surgical interventions within six months prior to screening;
• Chronic heart failure III-IV functional class according to the New York Heart Association (NYHA) classification;
• 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);
• Pregnant women, breastfeeding women, or women planning to become pregnant during the study or within 30 days after participation ends;
• 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;
• Current participation or planned participation by the patient in psychological or psychotherapeutic activities aimed at treating anxiety disorder during the clinical trial period;
• Participation in any other clinical trial within 90 days prior to the start of the screening period;
• Lack of patient cooperation;
• Other reasons, at the investigator's discretion, that may hinder the patient's participation in the study or pose unjustified risk to the patient.