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.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Patients of both sexes aged 18-45 years (inclusive).
âś“. Patients diagnosed with somatoform, stress-related, and other neurotic disorders (F43, F45, and F48), in accordance with the ICD-10 criteria.
✓. A moderate and severe anxiety (HADS score ≥ 11) documented at screening.
âś“. Patients providing signed Informed Consent form for participation in the clinical trial.
âś“. 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
✕. Moderate and severe depression symptoms recorded at screening (HADS score ≥ 11).
âś•. Organic, including symptomatic, mental disorders (F00-09).
âś•. Mental and behavioural disorders due to psychoactive substance use (F10-19).
âś•. Schizophrenia, schizotypal and delusional disorders (F20-29).
âś•. Mood \[affective\] disorders(F30-39).
âś•. Phobic (F40) and other anxiety disorders (F41), obsessive-compulsive disorder (F42), dissociative \[conversion\] disorders (F44), depersonalization-derealization syndrome (F48.1).
âś•. Behavioral syndromes associated with physiological disturbances and physical factors (F50-59).
What they're measuring
1
Change From Baseline in the Mean HAM-A Score at 12 Weeks of Treatment: 1. Group 1 (Tenoten®, 4 Tablets a Day); 2. Group 3 (Tenoten®, 8 Tablets a Day).