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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03036293
• Date of registration: 26/01/2017
• Prospective Registration: Yes
• Primary sponsor: Materia Medica Holding
• Public title: Clinical Trial of Tenoten® in the Treatment of Anxiety in Patients With Somatoform, Stress-related and Other Neurotic Disorders
• Scientific 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
• Date of first enrolment: February 8, 2017
• Target sample size: 390
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03036293
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Kazakhstan, Russian Federation

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anxiety

Intervention(s)

Drug: Placebo

Drug: Tenoten

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

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]

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]

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]

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]

Secondary ID(s)

MMH-TN-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors