RecruitingAnxietyNeurastheniaAdjustment Disorders

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

Eligible age

18–70 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

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About this study

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.

Sponsor: Valenta Pharm JSC

You may qualify if…

✓ 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;

You may not qualify if…

✕ 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:

Source: ClinicalTrials.gov · NCT06843044 · last updated 2025-07-08