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

Primary Purpose

Anxiety

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tenoten
Placebo
Sponsored by
Materia Medica Holding
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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).

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

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

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)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome

Secondary Outcome Measures

Change From Baseline in the Mean HAM-A Score at 4 Weeks of Treatment: 1.1. Group 1 (Tenoten®, 4 Tablets a Day); 1.2. Group 3 (Tenoten®, 8 Tablets a Day).
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome
The Mean HAM-A Score at 8 Weeks of Treatment: 2.1. Group 1 (Tenoten®, 4 Tablets a Day); 2.2. Group 3 (Tenoten®, 8 Tablets a Day).
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome
Percentage of Patients Had at Least a 50% Improvement in the HAM-A Score: 3.1. Group 1 (Tenoten® 4 Tablets a Day): After 4, 8 and 12 Weeks; 3.2. Group 3 (Tenoten® 8 Tablets a Day): After 4, 8 and 12 Weeks.
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome
Percentage of Patients With no Anxiety (HAM-A Score <14) in: 4.1. Group 1 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks; 4.3. Group 3 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks.
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome
Change From Baseline in the Total EQ-5D-3L Score at 12 Weeks of Treatment in Patients From: 5.1. Group 1 (Tenoten®, 4 Tablets a Day); 5.2. Group 3 (Tenoten®, 8 Tablets a Day).
European Quality of Life Instrument questionnaire (EQ-5D-3L) is designed for the evaluation of the quality of life.The score ranges between 5-15. Higher values represent a worse outcome.
Total CGI Scores in Patients From: 6.1. Group 1 (Tenoten®, 4 Tablets a Day); 6.2. Group 3 (Tenoten®, 8 Tablets a Day).
Clinical Global Impession (CGI) provides a brief assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. Total range 0-16. Higher values represent a worse outcome

Full Information

First Posted
January 26, 2017
Last Updated
December 3, 2020
Sponsor
Materia Medica Holding
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1. Study Identification

Unique Protocol Identification Number
NCT03036293
Brief Title
Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders
Official Title
International Multicenter, Double-blind, Randomized Placebo-controlled Phase IV Clinical Trial of Different Dosing Regimens of Tenoten® in the Treatment of Anxiety in Patients With Somatoform, Stress-related and Other Neurotic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
September 22, 2018 (Actual)
Study Completion Date
September 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Materia Medica Holding

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tenoten, 2 tablets twice daily (4 tablets/day)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo, 2 tablets twice daily (4 tablets/day)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Tenoten, 2 tablets 4 times daily (8 tablets/day)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo, 2 tablets 4 times daily (8 tablets/day)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tenoten
Intervention Description
Tablet for oral use.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet for oral use.
Primary Outcome Measure Information:
Title
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).
Description
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in the Mean HAM-A Score at 4 Weeks of Treatment: 1.1. Group 1 (Tenoten®, 4 Tablets a Day); 1.2. Group 3 (Tenoten®, 8 Tablets a Day).
Description
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome
Time Frame
4 weeks
Title
The Mean HAM-A Score at 8 Weeks of Treatment: 2.1. Group 1 (Tenoten®, 4 Tablets a Day); 2.2. Group 3 (Tenoten®, 8 Tablets a Day).
Description
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome
Time Frame
8 weeks
Title
Percentage of Patients Had at Least a 50% Improvement in the HAM-A Score: 3.1. Group 1 (Tenoten® 4 Tablets a Day): After 4, 8 and 12 Weeks; 3.2. Group 3 (Tenoten® 8 Tablets a Day): After 4, 8 and 12 Weeks.
Description
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome
Time Frame
4,8,12 weeks
Title
Percentage of Patients With no Anxiety (HAM-A Score <14) in: 4.1. Group 1 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks; 4.3. Group 3 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks.
Description
The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome
Time Frame
4,8,12 weeks
Title
Change From Baseline in the Total EQ-5D-3L Score at 12 Weeks of Treatment in Patients From: 5.1. Group 1 (Tenoten®, 4 Tablets a Day); 5.2. Group 3 (Tenoten®, 8 Tablets a Day).
Description
European Quality of Life Instrument questionnaire (EQ-5D-3L) is designed for the evaluation of the quality of life.The score ranges between 5-15. Higher values represent a worse outcome.
Time Frame
12 weeks
Title
Total CGI Scores in Patients From: 6.1. Group 1 (Tenoten®, 4 Tablets a Day); 6.2. Group 3 (Tenoten®, 8 Tablets a Day).
Description
Clinical Global Impession (CGI) provides a brief assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. Total range 0-16. Higher values represent a worse outcome
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Parfenov, DrMedSci
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kazakh National Medical University named after S.D. Asfendiyarov
City
Almaty
ZIP/Postal Code
050000
Country
Kazakhstan
Facility Name
South - Kazakhstan State Pharmaceutical Academy
City
Shymkent
ZIP/Postal Code
160019
Country
Kazakhstan
Facility Name
Municipal Autonomous Healthcare Institution Order of the Red Banner of Labor City Clinical Hospital No. 1
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
City
Kazan'
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
The State Autonomic Health Care institution "Interregional clinical and diagnostical center"
City
Kazan'
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
LLC "City Center for Neurology and Pain Management"
City
Kazan'
ZIP/Postal Code
420110
Country
Russian Federation
Facility Name
Limited Liability Company "Family policlinic no. 4"
City
Korolev
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
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
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
The State Budget Health Care institution of Moscow the City "City clinical hospital No. 12 of the Administration of Health Care of Moscow City"
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
Pirogov Russian National Research Medical University
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
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
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
State budgetary institution of public health services of the Nizhniy Novgorod region "Nizhegorod Regional Clinical Hospital named after NA Semashko"
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
LLC "City Neurological Center" Sibneyromed "
City
Novosibirsk
ZIP/Postal Code
630064
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University/Department of Neurology and Manual Medicine
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University/Department of Neurology with Clinic
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State-Funded Healthcare Institution of the Samara Region "Samara City N.I. Pirogov Clinical Hospital №1"
City
Samara
ZIP/Postal Code
443096
Country
Russian Federation
Facility Name
Saratov State Medical University named after V. I. Razumovsky
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
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
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
The state budgetary health care institution of the Vladimir region "Regional Clinical Hospital"
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Volgograd State Medical University
City
Volgograd
ZIP/Postal Code
400131
Country
Russian Federation
Facility Name
The State Health Care Institution Yaroslavl region "Clinical Hospital №8
City
Yaroslavl'
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
34930979
Citation
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.
Results Reference
derived

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

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