Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders
Condition: Anxiety
MeSH terms: Neurotic Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Design: an international, a multicenter, double-blind, randomized, parallel group
      placebo-controlled trial to evaluate efficacy and safety of study treatment.

      The study will enroll outpatient subjects of both genders aged 18-45 years with verified
      diagnoses of somatoform, stress-related and other neurotic disorders (F43, F45, F48) and
      signs of clinically relevant anxiety according to The Hospital Anxiety and Depression scale
      (HADS).

      After signing the informed consent form to participate in the clinical study the subject will
      be interviewed (complaints, medical history, concomitant therapy) and objective examination
      will be performed; the subject will fill HADS scale. The severity of anxiety at screening
      should be ≥ 11 according to HADS. If the subject meets inclusion criteria and has no
      exclusion criteria he/she will be enrolled into the study. The investigator will determine
      the severity of anxiety using НАМ-А scale; the subject will fill EQ-5D-3L questionnaire. At
      Visit 1 (Day 1) the subject will be randomized into one of the treatment groups:

        -  Group 1: Tenoten® at 2 tablets twice daily (4 tablets/day);

        -  Group 2: Placebo at 2 tablets twice daily (4 tablets/day);

        -  Group 3: Tenoten® at 2 tablets 4 daily (8 tablets/day).

        -  Group 4: Placebo at 2 tablets 4 daily (8 tablets/day). The first dose should be
           administered at Visit 1 after the visit procedures are completed. Further administration
           of the study product will be made according to the dosing scheme. The subject will
           administer the study product and will be followed for 12 weeks during which additional
           three visits will be made. At Visit 2 (Week 4), Visit 3 (Week 8) and Visit 4 (Week 12)
           the physician will record patients' complaints and physical examination data, fill HAM-A
           scale, check the study and concomitant therapy, assess treatment safety and patient
           compliance with the study treatment. At the final Visit 4 the subject will fill EQ-5D-3L
           questionnaire and the investigator will fill the Clinical Global Impression Scale
           Efficacy Index (CGI-EI).

      Subjects will be allowed to take symptomatic therapy and medications for their co-morbidities
      during the study, except for the medicines listed in "Prohibited therapy".
    

Intervention name(s): Tenoten; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet for oral use.; Tablet for oral use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment