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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

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:

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

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 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 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).

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.

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.

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

NCT ID

NCT03036293

First Posted

January 26, 2017

Last Updated

December 3, 2020

Sponsor

Materia Medica Holding

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

Time Frame

8 weeks

Title

Description

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

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

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

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

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

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