Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study is to evaluate the efficacy and safety of the drug Ranquilon, 1 mg tablets, at a dosage of 6 mg/day compared to the drug Afobazole, 10 mg tablets, at a dosage of 30 mg/day for the treatment of patients with anxiety disorders due to neurasthenia and adjustment disorders.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranquilon, 6 mg/day | Experimental | Ranquilon, 1 mg tablets, at a dosage of 6 mg/day for 28 days |
|
| Afobazole, 30 mg/day | Active Comparator | Afobazole, 10 mg tablets, at a dosage of 30 mg/day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranquilon | Drug | 1 mg tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with a significant reduction in anxiety levels (by 50% or more) on Hamilton Anxiety Rating Scale (HARS) compared to baseline on Day 29 ± 1 (Visit 3) | HARS scale includes 14 items, each of which is rated on the Likken scale (from 0 points as absence of the symptom to 4 points as the worst possible symptom). Of these, 13 items relate to the manifestation of anxiety in daily life, 14th item relate to the manifestation of anxiety during examinations. | Day 29 ± 1 (Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety levels according to the Hamilton Anxiety Rating Scale (HARS) scale on Day 29 ± 1 (Visit 3) compared to baseline | HARS scale includes 14 items, each of which is rated on the Likken scale (from 0 points as absence of the symptom to 4 points as the worst possible symptom). Of these, 13 items relate to the manifestation of anxiety in daily life, 14th item relate to the manifestation of anxiety during examinations. |
Not provided
Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
The patient's decision to withdraw from the study (revocation of informed consent);
Each patient has the right to discontinue participation in the study at any time without explanation. Withdrawal from the study will not affect the medical care provided to the patient in the future;
The investigator's decision that the patient needs to be excluded in the best interest of the patient;
The patient refuses to cooperate with the investigator or is non-compliant;
Emergence of reasons/situations during the study that threaten the patient's safety (e.g., hypersensitivity reactions, serious adverse events, etc.);
Inclusion of a patient in the study that does not meet the inclusion/exclusion criteria, including cases of deviation from normal values in laboratory test results obtained at Visit 0;
Significant violation of the treatment regimen.
A significant violation is considered:
Positive pregnancy test;
Confirmed diagnosis of COVID-19;
Emergence of other reasons during the study that prevent its conduct according to the protocol;
Patient death;
Sponsor-initiated study termination;
Termination of the study by the Investigator;
Termination of the study by regulatory authorities.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region | Recruiting | Engel's | 413090 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009440 | Neurasthenia |
| D000275 | Adjustment Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D013001 | Somatoform Disorders |
| D000068099 | Trauma and Stressor Related Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C520797 | GB-115 |
| C410924 | 2-((2-morpholino)ethylthio)-5-ethoxybenzimidazole |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Afobazole | Drug | 10 mg tablets |
|
|
| Day 29 ± 1 (Visit 3) |
| Proportion of patients with a reduction in anxiety levels on the Hamilton Anxiety Rating Scale (HARS) scale to 17 points or less on Day 29 ± 1 (Visit 3) | HARS scale includes 14 items, each of which is rated on the Likken scale (from 0 points as absence of the symptom to 4 points as the worst possible symptom). Of these, 13 items relate to the manifestation of anxiety in daily life, 14th item relate to the manifestation of anxiety during examinations. | Day 29 ± 1 (Visit 3) |
| Proportion of patients with a score of 2 points or less on the Clinical Global Impression (CGI-s) scale as assessed by the physician (healthy or borderline disorder) on Day 29 ± 1 (Visit 3) | The scale ranges from 1 to 7 points, where 1 indicates healthy and 7 indicates very severe disorder. | Day 29 ± 1 (Visit 3) |
| Change in the severity of the patient's condition on the Clinical Global Impression (CGI-s) scale by Day 29 ± 1 (Visit 3) compared to baseline | The scale ranges from 1 to 7 points, where 1 indicates healthy and 7 indicates very severe disorder. | Day 29 ± 1 (Visit 3) |
| Change in the total score on the Multidimensional Fatigue Inventory (MFI-20) on Day 29 ± 1 (Visit 3) compared to baseline | If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible). | Day 29 ± 1 (Visit 3) |
| Proportion of patients with a reduction in total score on the Multidimensional Fatigue Inventory (MFI-20) by 25% on Day 29 ± 1 (Visit 3) compared to baseline | Normally, the total number of points should not exceed 30. If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible). | Day 29 ± 1 (Visit 3) |
| Proportion of patients with a reduction in total score on the Multidimensional Fatigue Inventory (MFI-20) by 50% on Day 29 ± 1 (Visit 3) compared to baseline | Normally, the total number of points should not exceed 30. If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible). | Day 29 ± 1 (Visit 3) |
| Proportion of patients with a total score on the Multidimensional Fatigue Inventory (MFI-20) reduced to 30 points or less on Day 29 ± 1 (Visit 3) | Normally, the total number of points should not exceed 30. If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible). | Day 29 ± 1 (Visit 3) |
| Absolute value of the patient's self-assessment of their subjective condition for all individual items on the Multidimensional Fatigue Inventory (MFI-20) scale by Day 29 ± 1 (Visit 3) | Normally, the total number of points should not exceed 30. If the total score on any of the subscales (General Fatigue, Reduced Activity, Decreased Motivation, Physical Fatigue, Mental Fatigue) is above 12, it may serve as preliminary grounds for diagnosing "asthenic syndrome." Each subscale is assessed from 4 points (lack of symptoms) to 20 points (worst symptoms possible). | Day 29 ± 1 (Visit 3) |
| Change in total score on the Columbia-Suicide Severity Rating Scale (C-SSRS) by Day 29 ± 1 (Visit 3) compared to baseline | A severity rating of "3" or higher indicates a serious risk of suicide. A rating of "5" and any identified suicidal actions indicate an extremely high risk and an absolute necessity for urgent therapeutic measures and hospitalization. The section "intensity of suicidal thoughts" allows for a more accurate assessment of severity and prediction of its dynamics. | Day 29 ± 1 (Visit 3) |
| Change in total score on the Emotional Eating Questionnaire by Day 29 ± 1 (Visit 3) compared to baseline | The scale ranges from 0 to 30 points, where a minimum indicates no emotional overeating and a maximum indicates a strong dependence of eating behavior on emotional state. | Day 29 ± 1 (Visit 3) |
| Change in total score on the Psychological Stress Measure (PSM-25) by Day 29 ± 1 (Visit 3) compared to baseline | A score below 99 indicates low stress, a score between 100-125 indicates moderate stress; a score above 125 indicates high stress | Day 29 ± 1 (Visit 3) |
| Safety and Tolerability: adverse event (AE) rate | Number and frequency of adverse events (AEs) or serious AEs (SAEs) | From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 43 ± 1 for each participant |
| Safety and Tolerability: AEs associated with the study drug | Number and frequency of AEs or SAEs associated with the study drug | From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 43 ± 1 for each participant |
| Safety and Tolerability: treatment discontinuation | Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs | From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 43 ± 1 for each participant |
| Safety and Tolerability: vital signs - systolic blood pressure (SBP) | SBP, mmHg | Screening, day 1, day 29 ± 1, day 43 ± 1 |
| Safety and Tolerability: vital signs - diastolic blood pressure (DBP) | DBP, mmHg | Screening, day 1, day 29 ± 1, day 43 ± 1 |
| Safety and Tolerability: vital signs - respiratory rate (RR) | RR, breaths per minute | Screening, day 1, day 29 ± 1, day 43 ± 1 |
| Safety and Tolerability: vital signs - heart rate (HR) | HR, beats per minute | Screening, day 1, day 29 ± 1, day 43 ± 1 |
| Safety and Tolerability: vital signs - body temperature | Body temperature, Celsius scale | Screening, day 1, day 29 ± 1, day 43 ± 1 |
| Safety and Tolerability: concomitant treatment | Data on concomitant treatment (if any) | From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 43 ± 1 for each participant |
| Safety and Tolerability: clinical blood test - hemoglobin | Hemoglobin (g/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - hematocrit | Hematocrit (%) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - red blood cell count | Red blood cell count (cells/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - platelet count | Platelet count (cells/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - leukocyte count | Leukocyte count (cells/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate | Erythrocyte sedimentation rate (mm/h) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - myelocytes | Leukocyte formula (myelocytes, %) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - band neutrophils | Leukocyte formula (band neutrophils, %) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - segmented neutrophils | Leukocyte formula (eosinophils, %) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - basophils | Leukocyte formula (basophils, %) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - monocytes | Leukocyte formula (monocytes, %) | Screening, day 29 ± 1 |
| Safety and Tolerability: clinical blood test - lymphocytes | Leukocyte formula (lymphocytes, %) | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - specific gravity | Specific gravity of the urine | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - color | Color of the urine | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - transparency | Transparency of the urine | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - pH | pH of the urine | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - protein | Protein concentration (g/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - glucose | Glucose concentration (mmol/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - red blood cells | Red blood cell content (number in sight) | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - white blood cells | White blood cell content (number in sight) | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - epithelial cells | Epithelial cell content (number in sight) | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - ketone bodies | Ketone bodies (mmol/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: urinalysis - urobilinogen | Urobilinogen (mcmol/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: blood chemistry - glucose | Glucose concentration (mmol/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: blood chemistry - cholesterol | Total cholesterol concentration (mmol/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: blood chemistry - protein | Total protein concentration (g/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: blood chemistry - bilirubin | Total bilirubin concentration (micromol/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: blood chemistry - creatinine | Creatinine concentration (micromol/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: blood chemistry - alkaline phosphatase | Alkaline phosphatase activity (U/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: blood chemistry - alanine transaminase | Alanine transaminase activity (U/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: blood chemistry - aspartate transaminase | Aspartate transaminase activity (U/L) | Screening, day 29 ± 1 |
| Safety and Tolerability: blood chemistry - urea | Urea concentration (mmol/L) | Screening, day 29 ± 1 |
| Unimed-C Jsc | Recruiting | Moscow | 119571 | Russia |
|
| Aurora MedFort LLC | Recruiting | Saint Petersburg | 194156 | Russia |
|
| Limited Liability Company "Research Center Eco-Safety" | Recruiting | Saint Petersburg | 196143 | Russia |
|
| Limited Liability Company "Stepmed Clinic" | Recruiting | Saint Petersburg | Russia |
|
| Saratov City Psychoneurological Dispensary | Recruiting | Saratov | 410038 | Russia |
|