Phase 4
N=390
Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03036293 ↗Enrolled (actual)
390
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: 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). — 18.81; 18.38; 17.88; 7.26 score on a scale — p=0.0055
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tenoten (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Materia Medica Holding
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
18.81; 18.38; 17.88; 7.26; 6.40; 8.48 | 0.0055 sig |
| SECONDARY 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). |
18.81; 18.38; 17.88; 13.73; 13.31; 13.85 | 0.08 |
| SECONDARY 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). |
18.81; 18.38; 17.88; 10.61; 9.88; 10.81 | 0.21 |
| SECONDARY 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. |
16; 18; 14; 44; 55; 45 | 0.065 |
| SECONDARY 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. |
58; 63; 66; 91; 105; 96 | 0.46 |
| SECONDARY 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). |
7.44; 7.42; 7.48; 5.84; 5.71; 6.05 | 0.314 |
| SECONDARY Total CGI Scores in Patients From: 6.1. Group 1 (Tenoten®, 4 Tablets a Day); 6.2. Group 3 (Tenoten®, 8 Tablets a Day). |
4.53; 4.55; 5.71 | 0.0021 sig |
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.
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).
Data sourced from ClinicalTrials.gov (NCT03036293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.