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

NCT03036293 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2020-12-31

Study results available
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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.

Conditions

Interventions

DRUG

Tenoten

Tablet for oral use.

DRUG

Placebo

Tablet for oral use.

Sponsors & Collaborators

  • Materia Medica Holding

    lead INDUSTRY

Principal Investigators

  • Vladimir Parfenov, DrMedSci · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2018-09-22
Completion
2018-09-22

Countries

  • Kazakhstan
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03036293 on ClinicalTrials.gov