[Comparative study of the efficacy and safety of Ranquilon and Afobazol in the treatment of patients with anxiety associated with neurasthenia and adjustment disorders. (Results of an open, randomized, multicenter, phase IV clinical study)].

Authors

T A Karavayeva, A N Barinov, I V Egorov, E Yu Ebzeeva, K A Ishchenko

Published in

Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. Volume 126. Issue 7. Pages 51-62.

Abstract

To evaluate the efficacy and safety of Ranquilon¹ at 6 mg daily, compared with Afobazol (fabomotizole) at 30 mg daily, for the treatment of patients with anxiety associated with neurasthenia and adjustment disorders.
The clinical study included 200 patients diagnosed with anxiety associated with neurasthenia (F48.0) or adjustment disorder (F43.2). All participants had a Hamilton Anxiety Rating Scale (HARS) score of 18-24, demonstrated significant asthenia on the Multidimensional Fatigue Inventory (MFI-20) (score over 50), and scored at least 4 on the Clinical Global Impression-Severity (CGI-S) subscale. Participants were randomly assigned to two groups: Group 1 consisted of 100 patients receiving Ranquilon 1 mg tablets at 6 mg/day (2 tablets three times daily) for 28 days, while Group 2 consisted of 100 patients receiving Afobazol (fabomotizole) 10 mg tablets at 30 mg/day (1 tablet three times daily) for the same duration. The assessment of therapeutic response used the HARS, the Psychological Stress Measure (PSM-25) to evaluate stress levels, the MFI-20 scale to assess asthenia, and the CGI-S subscale to assess the severity of the condition. Monitoring for adverse events (AEs), serious adverse events (SAEs), and clinically significant changes in vital signs, laboratory tests, and ECG parameters was used for safety assessment.
The proportion of responders with a 50% or greater reduction in mean HARS scores at Visit 3 (Day 29±1) compared to baseline (Visit 0) was statistically higher (p<0.043) in Group 1 (63.3%, n=62) vs. Group 2 (49.0%, n=49). All secondary efficacy criteria further demonstrated statistically significant advantages for Group 1 compared to Group 2 (p<0.05). In total, 29 AEs were reported in 14.0% (n=44) of patients, including 16 AEs in 16.0% (n=16) of patients from Group 1 and 13 AEs in 12.0% (n=12) of patients from Group 2. There was no significant difference between the treatment groups in the number of patients with AEs (p=0.4150). Both groups reported only mild AEs, with none serious, severe, or fatal, and none leading to discontinuation of study treatment. No clinically significant abnormalities were observed in vital signs, laboratory tests, or ECG assessments.
Ranquilon 1 mg tablets at 6 mg/day demonstrate greater efficacy than Afobazol 10 mg tablets at 30 mg/day in alleviating anxiety associated with neurasthenia and adjustment disorders. The safety profile of Ranquilon is favorable and comparable to that of Afobazol.

PMID:
42565399
Bibliographic data and abstract were imported from PubMed on 07 Aug 2026.

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