Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders
Condition: Anxiety
MeSH terms: Neurotic Disorders
Intervention: Tenoten; Placebo
Intervention description: Tablet for oral use.; Tablet for oral use.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 390.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both sexes aged 18-45 years (inclusive).

          2. Patients diagnosed with somatoform, stress-related, and other neurotic disorders (F43,
             F45, and F48), in accordance with the ICD-10 criteria.

          3. A moderate and severe anxiety (HADS score ≥ 11) documented at screening.

          4. Patients providing signed Informed Consent form for participation in the clinical
             trial.

          5. Patients of reproductive age (of both sexes) using contraceptives and contraceptive
             methods during the study and for 30 days after the end of participation in the trial.

        Exclusion Criteria:

          1. Moderate and severe depression symptoms recorded at screening (HADS score ≥ 11).

          2. Organic, including symptomatic, mental disorders (F00-09).

          3. Mental and behavioural disorders due to psychoactive substance use (F10-19).

          4. Schizophrenia, schizotypal and delusional disorders (F20-29).

          5. Mood [affective] disorders(F30-39).

          6. Phobic (F40) and other anxiety disorders (F41), obsessive-compulsive disorder (F42),
             dissociative [conversion] disorders (F44), depersonalization-derealization syndrome
             (F48.1).

          7. Behavioral syndromes associated with physiological disturbances and physical factors
             (F50-59).

          8. Disorders of adult personality and behavior (F60-69).

          9. Intellectual disabilities (F70-79).

         10. Inflammatory and traumatic brain injuries with permanent neurological deficit.

         11. Prior diagnosis of a class III or IV cardiovascular disease (according to the New York
             Heart Association, 1964)

         12. Malignant neoplasms/suspected malignant neoplasms.

         13. An allergy/intolerance to any of the components of medications used in the treatment.

         14. Malabsorption syndrome (including hereditary or acquired lactase or other
             disaccharidase deficiency) and galactosemia.

         15. Any conditions that, from investigator's point of view, may affect the patient's
             ability to participate in the trial.

         16. Hospitalizations or surgeries scheduled for any date during the participation in the
             study.

         17. Patients who, from investigator's point of view, will fail to comply with the
             observation requirements of the trial or with the dosing regimen of the study drugs.

         18. Use of drugs listed in "Prohibited therapy" within a month prior to enrollment.

         19. Drug addiction, alcohol use in the amount over 2 units of alcohol a day.

         20. Pregnant or breast-feeding women.

         21. Participation in other clinical trials within 3 month prior to the enrollment in this
             study.

         22. Patients are related to the research personnel of the investigative site who are
             directly involved in the trial, or patients who are the immediate family member of the
             researcher. The 'immediate family member' includes husband/wife, parents, children or
             brothers (or sisters), regardless of whether they are natural or adopted.

         23. Patients working for OOO "NPF "MATERIA MEDICA HOLDING", i.e. the company's employee,
             temporary contract worker, or appointed official responsible for carrying out the
             research (or the immediate relative).