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Long-term treatment of generalised anxiety disorder with Aviandr: results of a 36-week post-registration observational study

https://doi.org/10.14412/2074-2711-2025-6-44-53

Abstract

The management of patients with generalised anxiety disorder (GAD) is a pressing issue in modern medicine. A new Russian drug, Aviandr (maritupridine), has demonstrated efficacy and good tolerability in the treatment of GAD in clinical trials.

Objective: To study the effectiveness of treating GAD with Aviandr in real clinical practice.

Material and methods. An open-label, non-comparative prospective study included 98 patients over the age of 18 with a confirmed diagnosis of GAD. Patients received Aviandr therapy and were monitored on an outpatient basis for 36 weeks. Clinical-psychopathological and psychometric examinations were conducted before treatment and at 2, 8, 16, 24, and 36 weeks after the start of treatment. Anxiety symptoms were measured using the Hamilton Anxiety Rating Scale (structured interview, SIGH-A). Additionally, symptoms of depression (Montgomery-Asberg Depression Rating Scale – MADRS), cognitive functions (Montreal Cognitive Assessment Scale – MoCA), and the somatic condition of patients were assessed.

Results. Aviandr has proven to be an effective drug for treating GAD. A statistically significant reduction in the total SIGH-A score was observed as early as the second week of therapy (from 22.06±5.80 before therapy to 19.12±5.91; p<0.001), followed by a progressive decrease by week 8 (14.12±5.44), week 16 (9.84±5.44), week 24 (7.44±5.13) and week 36 (6.90±6.20; p<0.001 for all visits). By the 36th week of therapy, the number of patients who responded to treatment (a decrease in the SIGH-A score by 50% or more from baseline) was 83.7%, and 66.7% of patients achieved remission (total SIGH-A score ≤7). Depressive symptoms on the MADRS scale decreased significantly from 14.60±7.62 at baseline to 4.15±5.33 at week 36 (p<0.001). Cognitive function scores on the MoCA scale improved significantly from 27.40±1.91 to 29.00±1.54 (p<0.001).

Conclusion. The use of Aviandr is an effective method of treating GAD. The therapeutic effect of the drug manifested itself gradually, demonstrating a progressive increase throughout the course of therapy, with maximum symptom reduction achieved by the 36th week of treatment.

About the Authors

M. A. Kinkulkina
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

Marina Arkadyevna Kinkulkina

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



B. A. Volel
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



E. A. Smolyarchuk
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



E. N. Morozov
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



A. V. Ivaschenko
ChemDiv Inc.
United States

12730 High Bluff Dr, Suite 100, San Diego CA 92130


Competing Interests:

There are no conflicts of interest



A. A. Ivaschenko
ChemRar Pharma LLC
Russian Federation

2A, Rabochaya St., Moscow Region, Khimki 11440


Competing Interests:

There are no conflicts of interest



N. N. Ivanets
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



V. G. Zilov
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



T. I. Avdeeva
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



Yu. G. Tikhonova
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



T. A. Izyumina
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



P. A. Belyaeva
“Support” Psychotherapy Centre LLC
Russian Federation

417, Lenin St., Build. 3, Stavropol 355029


Competing Interests:

There are no conflicts of interest



V. A. Dedkova
Eco-Safety Research Centre LLC
Russian Federation

65, Yuri Gagarin Ave., lit. A, Saint Petersburg, 196143


Competing Interests:

There are no conflicts of interest



O. V. Izmailova
Samara State Medical University
Russian Federation

89, Chapaevskaya St., Samara 443099


Competing Interests:

There are no conflicts of interest



D. A. Golovkina
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



E. M. Goncharova
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



D. S. Gorchakov
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



A. A. Ivaschenko
Lomonosov Moscow State University
Russian Federation

1, Leninskiye gory, Moscow 119991


Competing Interests:

There are no conflicts of interest



A. E. Morozov
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



V. V. Tarasov
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

8, Trubetskaya St., Build 2, Moscow 119991


Competing Interests:

There are no conflicts of interest



References

1. Generalized anxiety disorder: Clinical guidelines. Electronic publication. Moscow: Ministry of Health of the Russian Federation; 2024. Available at: https://cr.minzdrav.gov.ru/viewcr/457_3 (accessed 20.10.2025) (In Russ.).

2. Karavaeva TA, Vasil'eva AV, Poltorak SV, et al. Diagnostic algorithm and criteria of generalized anxiety disorder. Obozrenie psihiatrii i medicinskoj psihologii imeni V.M. Bekhtereva. 2015;(3):124-30 (In Russ.).

3. Tyrer P, Baldwin D. Generalised anxiety disorder. Lancet. 2006 Dec 16;368(9553):2156-66. doi: 10.1016/S0140-6736(06)69865-6

4. Romasenko LV, Aleksandrovskij YuA, Makhov VM, et al. Generalized anxiety disorder in patients of general medical practice: clinical features, therapy. Psychiatry and Psychopharmacotherapy. 2015;(3):56-9 (In Russ.).

5. Hoehn-Saric R, McLeod DR, Funderburk F, Kowalski P. Somatic symptoms and physiologic responses in generalized anxiety disorder and panic disorder: an ambulatory monitor study. Arch Gen Psychiatry. 2004 Sep;61(9):913-21. doi: 10.1001/arch-psyc.61.9.913

6. Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow

7. Kessler RC, Keller MB, Wittchen HU. The epidemiology of generalized anxiety disorder. Psychiatr Clin North Am. 2001 Mar;24(1):19-39. doi: 10.1016/s0193953x(05)70204-5

8. Lijster JM, Dierckx B, Utens EM, et al. The Age of Onset of Anxiety Disorders. Can J Psychiatry. 2017 Apr;62(4):237-46. doi: 10.1177/0706743716640757

9. Weisberg RB. Overview of generalized anxiety disorder: epidemiology, presentation, and course. J Clin Psychiatry. 2009;70(Suppl 2):4-9.

10. Mosolov SN, Alfimov PV. Algorithm for biological treatment of Generalized Anxiety Disorder. Current Therapy of Mental Disorders. 2015;(2):24-8 (In Russ.).

11. Bielski RJ, Bose A, Chang CC. A doubleblind comparison of escitalopram and paroxetine in the long-term treatment of generalized anxiety disorder. Ann Clin Psychiatry. 2005 AprJun;17(2):65-9. doi: 10.1080/10401230590932326

12. Cardoner N, Gutierrez-Rojas L, Saiz P, et al. Does pregabalin offer potential as a firstline therapy for generalized anxiety disorder? A meta-analysis of efficacy, safety, and costeffectiveness. Front Pharmacol. 2025 Feb 7;16:1483770. doi: 10.3389/fphar.2025.1483770

13. Gelenberg AJ, Lydiard RB, Rudolph RL, et al. Efficacy of venlafaxine extended-release capsules in nondepressed outpatients with generalized anxiety disorder: A 6-month randomized controlled trial. JAMA. 2000 Jun 21;283(23):3082-8. doi: 10.1001/jama.283.23.3082

14. Rickels K, Etemad B, Khalid-Khan S, et al. Time to relapse after 6 and 12 months' treatment of generalized anxiety disorder with venlafaxine extended release. Arch Gen Psychiatry. 2010 Dec;67(12):1274-81. doi: 10.1001/archgenpsychiatry.2010.170

15. Ivashchenko AA, Morozova MA, Vostokova NV, et al. Safety and efficacy of aviandr in patients with generalized anxiety disorder: A multicenter, randomized, doubleblind, placebo-controlled, dose-finding, pilot study. J Psychiatr Res. 2021 Nov;143:436-44. doi: 10.1016/j.jpsychires.2021.10.008

16. Morozova MA, Safarova TP, Gluskina LYa, et al. Double-blind, placebo-controlled study of the efficacy and tolerability of Aviandr® in the treatment of generalized anxiety disorder. Current Therapy of Mental Disorders. 2024;(3):216 (In Russ.). doi: 10.21265/PSYPH.2024.82.78.001

17. Freitas S, Simöes MR, Alves L, Santana I. Montreal cognitive assessment: validation study for mild cognitive impairment and Alzheimer disease. Alzheimer Dis Assoc Disord. 2013;27(1):37-43. doi: 10.1097/WAD.0b013e3182420bfe

18. Hamilton M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x

19. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382

20. Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.15325415.2005.53221.x

21. Bandelow B, Seidler-Brandler U, Becker A, et al. Meta-analysis of randomized controlled comparisons of psychopharmacological and psychological treatments for anxiety disorders. World J Biol Psychiatry. 2007;8(3):175-87. doi: 10.1080/15622970601110273

22. Gomez AF, Barthel AL, Hofmann SG. Comparing the efficacy of benzodiazepines and serotonergic anti-depressants for adults with generalized anxiety disorder: a meta-analytic review. Expert Opin Pharmacother. 2018 Jun;19(8):883-94. doi: 10.1080/14656566.2018.1472767

23. Mendez EM, Mills JA, Suresh V, et al. Trajectory and magnitude of response in adults with anxiety disorders: a Bayesian hierarchical modeling meta-analysis of selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and benzodiazepines. CNS Spectr. 2024 Jun;29(3):187-96. doi: 10.1017/S1092852924000142

24. Wang SM, Woo YS, Kim NY, et al. Agomelatine for the Treatment of Generalized Anxiety Disorder: A Meta-Analysis. Clin Psychopharmacol Neurosci. 2020 Aug 31;18(3):423-33. doi: 10.9758/cpn.2020.18.3.423

25. Stein MB, Sareen J. CLINICAL PRACTICE. Generalized Anxiety Disorder. N Engl J Med. 2015 Nov 19;373(21):2059-68. doi: 10.1056/NEJMcp1502514

26. Ivanets NN, Kinkul'kina MA, Avdeeva TI, Tikhonova YuG. Remote consequences of the long-term uncontrollable consumption of anxiolytics and hypnotics in elderly: a problem of drug dependence. S.S. Korsakov Journal of Neurology and Psychiatry. 2015;115(7):47-59 (In Russ.). doi: 10.17116/jnevro20151157147-59

27. Baldwin D, Woods R, Lawson R, Taylor D. Efficacy of drug treatments for generalised anxiety disorder: systematic review and metaanalysis. BMJ. 2011 Mar 11;342:d1199. doi: 10.1136/bmj.d1199

28. Goodman WK, Bose A, Wang Q. Treatment of generalized anxiety disorder with escitalopram: pooled results from double-blind, placebo-controlled trials. J Affect Disord. 2005 Aug;87(2-3):161-7. doi: 10.1016/j.jad.2004.11.011

29. Li X, Zhu L, Su Y, Fang S. Short-term efficacy and tolerability of venlafaxine extended release in adults with generalized anxiety disorder without depression: A meta-analysis. PLoS One. 2017 Oct 5;12(10):e0185865. doi: 10.1371/journal.pone.0185865

30. Li X, Zhu L, Zhou C, et al. Efficacy and tolerability of short-term duloxetine treatment in adults with generalized anxiety disorder: A meta-analysis. PLoS One. 2018 Mar 20;13(3):e0194501. doi: 10.1371/journal.pone.0194501

31. Pollack MH, Zaninelli R, Goddard A, et al. Paroxetine in the treatment of generalized anxiety disorder: results of a placebo-controlled, flexible-dosage trial. J Clin Psychiatry. 2001 May;62(5):350-7. doi: 10.4088/jcp.v62n0508

32. Rickels K, Pollack MH, Sheehan DV, Haskins JT. Efficacy of extended-release venlafaxine in nondepressed outpatients with generalized anxiety disorder. Am J Psychiatry. 2000 Jun;157(6):968-74. doi: 10.1176/appi.ajp.157.6.968

33. Rickels K, Zaninelli R, McCafferty J, et al. Paroxetine treatment of generalized anxiety disorder: a double-blind, placebo-controlled study. Am J Psychiatry. 2003 Apr;160(4):749-56. doi: 10.1176/appi.ajp.160.4.749

34. Pae CU, Wang SM, Han C, et al. Vortioxetine, a multimodal antidepressant for generalized anxiety disorder: a systematic review and meta-analysis. J Psychiatr Res. 2015 May;64:88-98. doi: 10.1016/j.jpsychires.2015.02.017

35. Allgulander C, Florea I, Huusom AK. Prevention of relapse in generalized anxiety disorder by escitalopram treatment. Int J Neuropsychopharmacol. 2006 Oct;9(5):495-505. doi: 10.1017/S1461145705005973

36. Stein DJ, Ahokas A, Albarran C, et al. Agomelatine prevents relapse in generalized anxiety disorder: a 6-month randomized, double-blind, placebo-controlled discontinuation study. J Clin Psychiatry. 2012 Jul;73(7):1002-8. doi: 10.4088/JCP.11m07493

37. Mulhall S, Andel R, Anstey KJ. Variation in symptoms of depression and anxiety in midlife women by menopausal status. Maturitas. 2018 Feb;108:7-12. doi: 10.1016/j.maturitas.2017.11.005


Review

For citations:


Kinkulkina MA, Volel BA, Smolyarchuk EA, Morozov EN, Ivaschenko AV, Ivaschenko AA, Ivanets NN, Zilov VG, Avdeeva TI, Tikhonova YG, Izyumina TA, Belyaeva PA, Dedkova VA, Izmailova OV, Golovkina DA, Goncharova EM, Gorchakov DS, Ivaschenko AA, Morozov AE, Tarasov VV. Long-term treatment of generalised anxiety disorder with Aviandr: results of a 36-week post-registration observational study. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2025;17(6):44-53. (In Russ.) https://doi.org/10.14412/2074-2711-2025-6-44-53

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ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)