Clinical Trial Details

NCT ID: NCT03036293
Date Last Changed: September 28, 2017

Overview

Research Study Summary

A Phase 4 clinical study for patients with Anxiety

Research Study Title

International Multicenter, Double-blind, Randomized Parallel Group Placebo-controlled Clinical Trial of Efficacy and Safety of Different Dosing Regimens of Tenoten® in the Treatment of Anxiety in Patients With Somatoform, Stress-related and Other Neurotic Disorders

Purpose

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.

To Learn more

Recruitment Details

Phase
4
Gender
All
Age
18 to 45 Years
Overall Status
Recruiting
Lead Sponsor
Materia Medica Holding
Duration
10 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 45 Years

Inclusion Criteria:

  1. Patients of both sexes aged 18-45 years inclusively.

  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 drugs" 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 works for OOO "NPF "MATERIA MEDICA HOLDING", i.e. is the company's employee, temporary contract worker, or appointed official responsible for carrying out the research (or the immediate relative).

Site Locations (15)

Country State City Zip Facility and Contact
Kazakhstan Shymkent 160019 South - Kazakhstan State Pharmaceutical Academy
Gulsum Duchshanova, Prof

Gulsum Duchshanova, Prof
Principal Investigator
Russian Federation Chelyabinsk 454048 Municipal Autonomous Healthcare Institution Order of the Red Banner of Labor City Clinical Hospital No. 1
Galina Belskaya, Prof.

Galina Belskaya, Prof.
Principal Investigator
Russian Federation Kazan' 420012 Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
Enver Bogdanov, Prof

Enver Bogdanov, Prof
Principal Investigator
Russian Federation Kazan' 420101 The State Autonomic Health Care institution "Interregional clinical and diagnostical center"
Dina Hasanova, Prof

Dina Hasanova, Prof
Principal Investigator
Russian Federation Kazan' 420110 LLC "City Center for Neurology and Pain Management"
Elena Mendelevich, MD, PhD

Elena Mendelevich, MD, PhD
Principal Investigator
Russian Federation Korolev 141060 Limited Liability Company "Family policlinic no. 4"
Konstantin Glushkov, MD

Konstantin Glushkov, MD
Principal Investigator
Russian Federation Moscow 115419 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
Alla Gecht, Prof

Alla Gecht, Prof
Principal Investigator
Russian Federation Moscow 115516 The State Budget Health Care institution of Moscow the City "City clinical hospital No. 12 of the Administration of Health Care of Moscow City"
Pavel Kamchatnov, Prof

Pavel Kamchatnov, Prof
Principal Investigator
Russian Federation Moscow 119992 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
Vladimir Parfenov, Prof

Vladimir Parfenov, Prof
Principal Investigator
Russian Federation Novosibirsk 630064 LLC "City Neurological Center" Sibneyromed "
Olga Doronina, MD

Olga Doronina, MD
Principal Investigator
Russian Federation Saint Petersburg 197022 Pavlov First Saint Petersburg State Medical University
Aleksandr Amelin, Prof

Aleksandr Amelin, Prof
Principal Investigator
Russian Federation Saint Petersburg 197022 Pavlov First Saint Petersburg State Medical University
Evgenij Barantsevich, Prof

Evgenij Barantsevich, Prof
Principal Investigator
Russian Federation Samara 443096 State-Funded Healthcare Institution of the Samara Region "Samara City N.I. Pirogov Clinical Hospital №1"
Tatyana Lokshtanova, MD

Tatyana Lokshtanova, MD
Principal Investigator
Russian Federation Smolensk 214018 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
Natalya Maslova, Prof

Natalya Maslova, Prof
Principal Investigator
Russian Federation Yaroslavl' 150030 The State Health Care Institution Yaroslavl region "Clinical Hospital №8
Natalya Pizova, Prof

Natalya Pizova, Prof
Principal Investigator

Contact

Mikhail Putilovskiy, MD
+74952761571 ext. 302
E-mail:

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