Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders

NCT ID: NCT03036293

Last Updated: 2020-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2018-09-22

Brief 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".

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tenoten, 2 tablets twice daily (4 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.

Group Type: EXPERIMENTAL

Tenoten

Intervention Type: DRUG

Tablet for oral use.

Placebo, 2 tablets twice daily (4 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablet for oral use.

Tenoten, 2 tablets 4 times daily (8 tablets/day)

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.

Group Type: EXPERIMENTAL

Tenoten

Intervention Type: DRUG

Tablet for oral use.

Placebo, 2 tablets 4 times daily (8 tablets/day)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablet for oral use.

Interventions

Tenoten

Tablet for oral use.

Intervention Type: DRUG

Placebo

Tablet for oral use.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Materia Medica Holding

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir Parfenov, DrMedSci

Role: PRINCIPAL_INVESTIGATOR

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Locations

Kazakh National Medical University named after S.D. Asfendiyarov

Almaty, , Kazakhstan

South - Kazakhstan State Pharmaceutical Academy

Shymkent, , Kazakhstan

Municipal Autonomous Healthcare Institution Order of the Red Banner of Labor City Clinical Hospital No. 1

Chelyabinsk, , Russia

Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation

Kazan', , Russia

The State Autonomic Health Care institution "Interregional clinical and diagnostical center"

Kazan', , Russia

LLC "City Center for Neurology and Pain Management"

Kazan', , Russia

Limited Liability Company "Family policlinic no. 4"

Korolyov, , Russia

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

Moscow, , Russia

The State Budget Health Care institution of Moscow the City "City clinical hospital No. 12 of the Administration of Health Care of Moscow City"

Moscow, , Russia

Pirogov Russian National Research Medical University

Moscow, , Russia

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

Moscow, , Russia

State budgetary institution of public health services of the Nizhniy Novgorod region "Nizhegorod Regional Clinical Hospital named after NA Semashko"

Nizhny Novgorod, , Russia

LLC "City Neurological Center" Sibneyromed "

Novosibirsk, , Russia

Pavlov First Saint Petersburg State Medical University/Department of Neurology and Manual Medicine

Saint Petersburg, , Russia

Pavlov First Saint Petersburg State Medical University/Department of Neurology with Clinic

Saint Petersburg, , Russia

State-Funded Healthcare Institution of the Samara Region "Samara City N.I. Pirogov Clinical Hospital №1"

Samara, , Russia

Saratov State Medical University named after V. I. Razumovsky

Saratov, , Russia

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

Smolensk, , Russia

The state budgetary health care institution of the Vladimir region "Regional Clinical Hospital"

Vladimir, , Russia

Volgograd State Medical University

Volgograd, , Russia

State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8

Yaroslavl, , Russia

The State Health Care Institution Yaroslavl region "Clinical Hospital №8

Yaroslavl, , Russia

Countries

Kazakhstan; Russia

References

Parfenov VA, Kamchatnov PR, Khasanova DR, Bogdanov EI, Lokshtanova TM, Amelin AV, Maslova NN, Pizova NV, Belskaya GN, Barantsevich ER, Duchshanova GA, Kamenova SU, Kolokolov OV, Glazunov AB. The randomized clinical trial results of the anxiety treatment in patients with somatoform dysfunction and neurotic disorders. Sci Rep. 2021 Dec 20;11(1):24282. doi: 10.1038/s41598-021-03727-5.

Reference Type: DERIVED

PMID: 34930979 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MMH-TN-001

Identifier Type: -

Identifier Source: org_study_id