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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 : August 6, 2019
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

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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) Drug: Tenoten
Safety and Efficiency

Placebo Comparator: Placebo, 2 tablets twice a day (4 tablets a day) Drug: Placebo
Safety and Efficiency

Experimental: Tenoten, 2 tablets 4 times daily (8 tablets a day) Drug: Tenoten
Safety and Efficiency

Placebo Comparator: Placebo, 2 tablets 4 times daily (8 tablets a day) Drug: Placebo
Safety and Efficiency




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



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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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Kazakhstan
Kazakh National Medical University named after S.D. Asfendiyarov
Almaty, Kazakhstan, 050000
South - Kazakhstan State Pharmaceutical Academy
Shymkent, Kazakhstan, 160019
Russian Federation
Municipal Autonomous Healthcare Institution Order of the Red Banner of Labor City Clinical Hospital No. 1
Chelyabinsk, Russian Federation, 454048
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
Kazan', Russian Federation, 420012
The State Autonomic Health Care institution "Interregional clinical and diagnostical center"
Kazan', Russian Federation, 420101
LLC "City Center for Neurology and Pain Management"
Kazan', Russian Federation, 420110
Limited Liability Company "Family policlinic no. 4"
Korolev, Russian Federation, 141060
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, Russian Federation, 115419
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, Russian Federation, 115516
Pirogov Russian National Research Medical University
Moscow, Russian Federation, 117997
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, Russian Federation, 119992
State budgetary institution of public health services of the Nizhniy Novgorod region "Nizhegorod Regional Clinical Hospital named after NA Semashko"
Nizhny Novgorod, Russian Federation, 603126
LLC "City Neurological Center" Sibneyromed "
Novosibirsk, Russian Federation, 630064
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Russian Federation, 197022
State-Funded Healthcare Institution of the Samara Region "Samara City N.I. Pirogov Clinical Hospital №1"
Samara, Russian Federation, 443096
Saratov State Medical University named after V. I. Razumovsky
Saratov, Russian Federation, 410012
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, Russian Federation, 214018
The state budgetary health care institution of the Vladimir region "Regional Clinical Hospital"
Vladimir, Russian Federation, 600023
Volgograd State Medical University
Volgograd, Russian Federation, 400131
The State Health Care Institution Yaroslavl region "Clinical Hospital №8
Yaroslavl', Russian Federation, 150030
State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8
Yaroslavl, Russian Federation, 150030
Sponsors and Collaborators
Materia Medica Holding

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Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT03036293     History of Changes
Other Study ID Numbers: MMH-TN-001
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: August 6, 2019
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