Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders

Summary

The purposes of this study are: * To further examine the efficacy and safety of Tenoten® in the treatment of anxiety in patients with somatoform, stress-related and other neurotic disorders. * To compare the efficacy of two dosing regimens of Tenoten® (4 tablets daily vs.8 tablets daily, both for 12 weeks) in the treatment of anxiety in patients with somatoform, stress-related and other neurotic disorders.

Timeline

Start

2017-02-08

Primary completion

2018-09-22

Completion

2018-09-22

Outcome

Met primary endpoint

registry analysis (superiority test); Tenoten, 2 Tablets Twice Daily (4 Tablets/Day) vs Placebo-2 + Placebo-4; p = 0.0055; Mean Difference (Final Values) 1.56 NCT03036293 ↗

registry analysis (superiority test); Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day) vs Placebo-2 + Placebo-4; p <0.0001; Mean Difference (Final Values) 2.56 NCT03036293 ↗

paper (pgroup 1/placebo = 0.0055, pgroup 3/placebo < 0.0001). PMID 34930979 ↗

Publications

• Parfenov VA, Kamchatnov PR, Khasanova DR, Bogdanov EI, Lokshtanova TM, Amelin AV, Maslova NN, Pizova NV, Belskaya GN, Barantsevich ER, Duchshanova GA, Kamenova SU, Kolokolov OV, Glazunov AB. The randomized clinical trial results of the anxiety treatment in patients with somatoform dysfunction and neurotic disorders. Sci Rep. 2021 Dec 20;11(1):24282. doi: 10.1038/s41598-021-03727-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenoten	Unknown	2 unknown	Oral

Indications