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

Valenta Pharm

Status and phase: Enrolling; Phase 4

Conditions: Adjustment Disorders; Anxiety; Neurasthenia

Treatments: Drug: Afobazole; Drug: Ranquilon

Study type: Interventional

Funder types: Industry

Identifiers

NCT06843044

RAN-04-05-2024

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Ranquilon, 6 mg/day

Experimental group

Description:

Ranquilon, 1 mg tablets, at a dosage of 6 mg/day for 28 days

Treatment:

Drug: Ranquilon

Afobazole, 30 mg/day

Active Comparator group

Description:

Afobazole, 10 mg tablets, at a dosage of 30 mg/day for 28 days

Treatment:

Drug: Afobazole