Evaluating Ranquilon for Anxiety Disorders Related to Neurasthenia and Adaptation Issues

An Open-label, Comparative, Randomized, Multicenter Phase IV Clinical Study to Evaluate the Clinical Efficacy and Safety of the Drug Ranquilon, Tablets, 1 mg, in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders

This study is testing if a new medication called Ranquilon can help people with anxiety related to neurasthenia and adaptation issues feel better compared to another medication called Afobazole.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Valenta Pharm JSC (Industry-sponsored)
• Locations: 6 sites (Engel's and 5 other locations)
• Trial ID: NCT06843044 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Ranquilon, administered at a dosage of 6 mg/day, compared to Afobazole at 30 mg/day in treating patients with anxiety disorders stemming from neurasthenia and adaptation disorders. Participants will be assessed based on established diagnostic criteria and severity scales to ensure appropriate inclusion. The study aims to provide insights into the effectiveness of Ranquilon in managing anxiety symptoms in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 18 to 70 with diagnosed anxiety disorders due to neurasthenia or adaptation reactions.

Not a fit: Patients with severe suicidal thoughts or those not meeting the specific diagnostic criteria for anxiety disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients suffering from anxiety disorders related to neurasthenia and adaptation issues.

How similar studies have performed: While this approach is focused on a specific drug comparison, similar studies evaluating anxiety treatments have shown promising results, indicating potential for success.

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 health-related information), and comply with the procedures outlined in the study protocol.

Non-inclusion Criteria:

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.

Exclusion Criteria:

1. The patient's decision to withdraw from the study (revocation of informed consent);
2. Each patient has the right to discontinue participation in the study at any time without explanation. Withdrawal from the study will not affect the medical care provided to the patient in the future;
3. The investigator's decision that the patient needs to be excluded in the best interest of the patient;
4. The patient refuses to cooperate with the investigator or is non-compliant;
5. Emergence of reasons/situations during the study that threaten the patient's safety (e.g., hypersensitivity reactions, serious adverse events, etc.);
6. Inclusion of a patient in the study that does not meet the inclusion/exclusion criteria, including cases of deviation from normal values in laboratory test results obtained at Visit 0;
7. Significant violation of the treatment regimen.

   A significant violation is considered:
   1. Missing doses of the study drugs for 2 consecutive days or more, or
   2. Taking a total number of tablets \< 80% or \> 120% of the full course (the full course for Ranquilon is 168 tablets, and for Afobazole, it is 84 tablets).
8. Positive pregnancy test;
9. Confirmed diagnosis of COVID-19;
10. Emergence of other reasons during the study that prevent its conduct according to the protocol;
11. Patient death;
12. Sponsor-initiated study termination;
13. Termination of the study by the Investigator;
14. Termination of the study by regulatory authorities.

Where this trial is running

Engel's and 5 other locations

• Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region — Engel's, Russia (Recruiting)
• Unimed-C Jsc — Moscow, Russia (Recruiting)
• Aurora MedFort LLC — Saint Petersburg, Russia (Recruiting)
• Limited Liability Company "Research Center Eco-Safety" — Saint Petersburg, Russia (Recruiting)
• Limited Liability Company "Stepmed Clinic" — Saint Petersburg, Russia (Recruiting)
• Saratov City Psychoneurological Dispensary — Saratov, Russia (Recruiting)

Conditions Anxiety; Neurasthenia; Adjustment Disorders