Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders
Anxiety
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes aged 18-45 years (inclusive).
- 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.
- Patients providing signed Informed Consent form for participation in the clinical trial.
- 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).
- Organic, including symptomatic, mental disorders (F00-09).
- Mental and behavioural disorders due to psychoactive substance use (F10-19).
- Schizophrenia, schizotypal and delusional disorders (F20-29).
- Mood [affective] disorders(F30-39).
- Phobic (F40) and other anxiety disorders (F41), obsessive-compulsive disorder (F42), dissociative [conversion] disorders (F44), depersonalization-derealization syndrome (F48.1).
- Behavioral syndromes associated with physiological disturbances and physical factors (F50-59).
- Disorders of adult personality and behavior (F60-69).
- Intellectual disabilities (F70-79).
- Inflammatory and traumatic brain injuries with permanent neurological deficit.
- Prior diagnosis of a class III or IV cardiovascular disease (according to the New York Heart Association, 1964)
- Malignant neoplasms/suspected malignant neoplasms.
- An allergy/intolerance to any of the components of medications used in the treatment.
- Malabsorption syndrome (including hereditary or acquired lactase or other disaccharidase deficiency) and galactosemia.
- Any conditions that, from investigator's point of view, may affect the patient's ability to participate in the trial.
- Hospitalizations or surgeries scheduled for any date during the participation in the study.
- 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.
- Use of drugs listed in "Prohibited therapy" within a month prior to enrollment.
- Drug addiction, alcohol use in the amount over 2 units of alcohol a day.
- Pregnant or breast-feeding women.
- Participation in other clinical trials within 3 month prior to the enrollment in this study.
- 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.
- 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).
Sites / Locations
- Kazakh National Medical University named after S.D. Asfendiyarov
- South - Kazakhstan State Pharmaceutical Academy
- Municipal Autonomous Healthcare Institution Order of the Red Banner of Labor City Clinical Hospital No. 1
- Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
- The State Autonomic Health Care institution "Interregional clinical and diagnostical center"
- LLC "City Center for Neurology and Pain Management"
- Limited Liability Company "Family policlinic no. 4"
- State Budget Health Care institution of Moscow the City "Scientific and practical psychoneurological center n.a. Z.P. Solovyov" of the Administration of Health Care of Moscow City
- The State Budget Health Care institution of Moscow the City "City clinical hospital No. 12 of the Administration of Health Care of Moscow City"
- Pirogov Russian National Research Medical University
- The State Budget Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care of the Russian Federation, Hospital of nervous diseases A.Y. Kozhevnikov
- State budgetary institution of public health services of the Nizhniy Novgorod region "Nizhegorod Regional Clinical Hospital named after NA Semashko"
- LLC "City Neurological Center" Sibneyromed "
- Pavlov First Saint Petersburg State Medical University/Department of Neurology and Manual Medicine
- Pavlov First Saint Petersburg State Medical University/Department of Neurology with Clinic
- State-Funded Healthcare Institution of the Samara Region "Samara City N.I. Pirogov Clinical Hospital №1"
- Saratov State Medical University named after V. I. Razumovsky
- The State Budget Educational institution of High Professional Training Smolensk State Medical University of Ministry of Health Care of the Russian Federation, Smolensk regional clinical hospital
- The state budgetary health care institution of the Vladimir region "Regional Clinical Hospital"
- Volgograd State Medical University
- The State Health Care Institution Yaroslavl region "Clinical Hospital №8
- State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Tenoten, 2 tablets twice daily (4 tablets/day)
Placebo, 2 tablets twice daily (4 tablets/day)
Tenoten, 2 tablets 4 times daily (8 tablets/day)
Placebo, 2 tablets 4 times daily (8 tablets/day)
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.