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Clinical Trial of Tenoten® in the Treatment of Anxiety in Patients With Somatoform, Stress-related and Other Neurotic Disorders

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ClinicalTrials.gov Identifier: NCT03036293
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

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.

Condition or disease Intervention/treatment Phase
Anxiety Drug: Tenoten Drug: Placebo Phase 4

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 information sheet |(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. Degree of anxiety at screening should be ≥ 11 according to HADS. Where the subject meets inclusion criteria and has no exclusion criteria he/she will be enrolled into the study. The investigator will determine degree 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 of the product 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 determine Clinical Global Impression Scale Efficacy Index (CGI-EI) score.

Subjects will be allowed to take symptomatic therapy and medications for their co-morbidities in the course of the study, except for the medicines listed in "Forbidden concomitant therapy".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : September 22, 2018
Actual Study Completion Date : September 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Tenoten, 2 tablets twice a day (4 tablets a day)
Oral administration. Dose per administration: 2 tablets. The product should be administered outside of meals (between meals or fluid intakes), the tablets should be held in mouth until complete dissolution.
Drug: Tenoten
Oral administration.

Placebo Comparator: Placebo, 2 tablets twice a day (4 tablets a day)
Oral administration. Dose per administration: 2 tablets. The product should be administered outside of meals (between meals or fluid intakes), the tablets should be held in mouth until complete dissolution.
Drug: Placebo
Oral administration.

Experimental: Tenoten, 2 tablets 4 times daily (8 tablets a day)
Oral administration. Dose per administration: 2 tablets. The product should be administered outside of meals (between meals or fluid intakes), the tablets should be held in mouth until complete dissolution.
Drug: Tenoten
Oral administration.

Placebo Comparator: Placebo, 2 tablets 4 times daily (8 tablets a day)
Oral administration. Dose per administration: 2 tablets. The product should be administered outside of meals (between meals or fluid intakes), the tablets should be held in mouth until complete dissolution.
Drug: Placebo
Oral administration.




Primary Outcome Measures :
  1. Change from baseline in the mean HAM-A score at 12 weeks of treatment in patients from: 1. Group 1 (Tenoten®, 4 tablets a day); 2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 12 weeks ]
    HAM-A


Secondary Outcome Measures :
  1. Change from baseline in the mean HAM-A score at 4 weeks of treatment in patients from: 1.1. Group 1 (Tenoten®, 4 tablets a day); 1.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 4 weeks ]
    HAM-A

  2. The mean HAM-A score at 8 weeks of treatment versus baseline in patients from: 2.1. Group 1 (Tenoten®, 4 tablets a day); 2.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 8 weeks ]
    HAM-A

  3. Percentage of patients achieving at least a 50% improvement in the HAM-A score from baseline in: 3.1. Group 1 (Tenoten®, 4 tablets a day) 3.1.1. at 4 weeks; 3.1.2. at 8 weeks; 3.1.3. at 12 weeks; 3.2. Group 3 (Tenoten®, 8 tablets a day) 3.2.1. at [ Time Frame: 4,8,12 weeks ]
    HAM-A

  4. Percentage of patients with no anxiety (HAM-A score <14) in: 4.1. Group 1 (Tenoten®, 4 tablets a day) 4.1.1. at 4 weeks; 4.1.2. at 8 weeks; 4.1.3. at 12 weeks; [ Time Frame: 4,8,12 weeks ]
    HAM-A

  5. 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). [ Time Frame: 12 weeks ]
    EQ-5D-3L

  6. Total CGI scores in patients from: 6.1. Group 1 (Tenoten®, 4 tablets a day); 6.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 12 weeks ]
    CGI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036293


Locations
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Sponsors and Collaborators
Materia Medica Holding
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Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT03036293    
Other Study ID Numbers: MMH-TN-001
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Neurotic Disorders
Mental Disorders