Optimal dosage regimen of Ranquilon® for patients with anxiety associated with neurasthenia and adaptation disorders: phase II clinical trial

Aim

To determine the optimal dosing of Ranquilon® (N-(6-phenylhexanoyl)-glycyl-L-tryptophan amide) tablets (Valenta Pharm JSC) for the treatment of patients with anxiety associated with neurasthenia and adjustment disorders.

Material and methods

In the double-blind placebo-controlled randomized prospective study, 168 adult patients with anxiety associated with neurasthenia nervosa and adjustment spectrum disorders were randomized into 4 groups and were treated with Ranquilon® 3 mg, 6 mg or 9 mg daily or placebo. The efficacy of therapy was assessed using the Clinical Global Impression (CGI-i) and severity (CGI-s) subscales, as well as the Hamilton Anxiety Rating Scale (HARS) and the Multidimensional Fatigue Inventory (MFI-20). To evaluate safety we monitored vital signs, laboratory parameters and electrocardiogram (ECG) and recorded the number and severity of adverse events and serious adverse events throughout the study.

Results

Administration of Ranquilon® at a daily dose of 6 mg was the most effective in achieving the primary endpoint (proportion of patients with significant and marked improvement as assessed by a physician [CGI-i score of 1 or 2] on Day 29 ± 1), showing statistically significant superiority over placebo (p = 0.0148).

Conclusion

Daily dose of Ranquilon 6 mg is optimal for the treatment of patients with anxiety disorders in neurasthenia and adjustment disorders and is recommended for phase III studies.

Key words

anxiety disorders, neurasthenia, adjustment disorders, Ranquilon.