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This is a multi-centre, observational, non-interventional study, which will prospectively collect clinical and socio-demographic data from patients with depression occurred after COVID 19 in real clinical settings during 8 weeks of treatment.
10 clinics and 10 of psychiatrists and neurologists across the country will participate in the study and it is estimated that each investigating physician will enroll 10 patients.
A patient with depression occurred within 3 month period after onset of confirmed COVID 19 infection who has already been recommended to initiate antidepressive treatment with agomelatine will be asked to provide a consent to participate in the study and in case of consent is positive the patient will be invited for 3 more visits starting from the date of the inclusion in the study according to clinical practice. Therefore clinical parameters needed for describing effectiveness and tolerability of agomelatine treatment will be prospectively collected at each of these visits. Antidepressive treatment of enrolled outpatients can be modified by investigating psychiatrist or neurologist at any time of the observation if required.
Following visits are planned:
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| Measure | Description | Time Frame |
|---|---|---|
| Antidepressive Effectiveness of Agomelatine in Patients With Depression Episode Occurred After COVID-19 Assessed by HAMD-17 After 8 Weeks of Treatment in the Daily Clinical Practice. | Mean change from baseline (BL) in total HAMD-17 (Hamilton Depression Rating Scale) score assessed at week 8 of the observational period. Assessment of the severity of condition using HAMD-17 (total score is reported, the total range from 0 to 51, where 0 score is no symptoms - 51 is for severe depression): 0 - 7 "normal" (no marked symptoms of anxiety and depression), 8 - 15 "mild depression", 16 - 24 "moderate depression", 25 - 51 "severe depression" | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Agomelatine on Anxiety Symptoms Assotiated With the Depression and Assessed by HAMD-17 (Item 10 and Item 11) Baseline and 8 Weeks of Treatment of Patients Included in the Study. | Mean change from baseline (BL) in HAMD-17 (Hamilton Depression Rating Scale) in item 10 (Psychic anxiety ) and item 11 (Somatic anxiety ) after 8 weeks of treatment of patients included in the study.. Assessment of the severity in item 10: 0- No difficulty
Assessment of the severity in item 11: 0- Absent
|
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Inclusion Criteria:
Exclusion Criteria:
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patients with depression occurred after COVID 19
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia" | Moscow | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Depression Occurred After COVID 19 | Patients with the major depressive disorder (total score 8-24 on HAMD-17 - The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. It consists of 20 questions. For assessment of the severity of condition using a summary of total score where 0 - 7 "normal", 8 - 15 "mild depression",16 - 24 "moderate depression", 25 and more "severe depression" Depression treatment by agomelatine according to SMPC (Summary of Product Characteristics) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Depression Occurred After COVID 19 | Patients with the major depressive disorder (total score 8-24 on HAMD-17 - The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. It consists of 20 questions. For assessment of the severity of condition using a summary of total score where 0 - 7 "normal", 8 - 15 "mild depression",16 - 24 "moderate depression", 25 and more "severe depression" Depression treatment by agomelatine according to SMPC (Summary of Product Characteristics) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antidepressive Effectiveness of Agomelatine in Patients With Depression Episode Occurred After COVID-19 Assessed by HAMD-17 After 8 Weeks of Treatment in the Daily Clinical Practice. | Mean change from baseline (BL) in total HAMD-17 (Hamilton Depression Rating Scale) score assessed at week 8 of the observational period. Assessment of the severity of condition using HAMD-17 (total score is reported, the total range from 0 to 51, where 0 score is no symptoms - 51 is for severe depression): 0 - 7 "normal" (no marked symptoms of anxiety and depression), 8 - 15 "mild depression", 16 - 24 "moderate depression", 25 - 51 "severe depression" | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Depression Occurred After COVID 19 | Patients with the major depressive disorder (total score 8-24 on HAMD-17 - The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. It consists of 20 questions. For assessment of the severity of condition using a summary of total score where 0 - 7 "normal", 8 - 15 "mild depression",16 - 24 "moderate depression", 25 and more "severe depression" Depression treatment by agomelatine according to SMPC (Summary of Product Characteristics) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| inefficiency of treatment | Psychiatric disorders | MedDRA v.25.1. | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denis Morozov | Sevier | 8-495-93707-00 | denis.morozov@servier.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2022 | Jun 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2022 | Jun 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| 8 weeks |
| Effectiveness of Agomelatine on Global Improvement and Social Functioning Assessed by CGI-I (Clinical Global Impression -Improvement) Score After 8 Weeks of Treatment of Patients Included in the Study. | The clinical global impression - improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The best is - "Very much improved" - 0 scores and "Very much worse"- 6 scores - is the worest | 8 weeks |
| Effectiveness of Agomelatine on Quality of Life in Patients With Depression Episode Occurred After COVID-19 Assessed by SF-36 Questionnaire After 8 Weeks of Treatment of Patients Included in the Study. | The Short Form (36) Health Survey (SF36 ) scale questioner was used. SF36 is is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 8 weeks |
| Tolerability of Agomelatine After 8 Weeks of Treatment Based on Rate of Adverse Events Leading to Drug Discontinuation in Patients Included in the Study. | Number of adverse events/ adverse drug reactions leading to drug discontinuation during the observational period. | 8 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Effectiveness of Agomelatine on Anxiety Symptoms Assotiated With the Depression and Assessed by HAMD-17 (Item 10 and Item 11) Baseline and 8 Weeks of Treatment of Patients Included in the Study. | Mean change from baseline (BL) in HAMD-17 (Hamilton Depression Rating Scale) in item 10 (Psychic anxiety ) and item 11 (Somatic anxiety ) after 8 weeks of treatment of patients included in the study.. Assessment of the severity in item 10: 0- No difficulty
Assessment of the severity in item 11: 0- Absent
| Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Effectiveness of Agomelatine on Global Improvement and Social Functioning Assessed by CGI-I (Clinical Global Impression -Improvement) Score After 8 Weeks of Treatment of Patients Included in the Study. | The clinical global impression - improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The best is - "Very much improved" - 0 scores and "Very much worse"- 6 scores - is the worest | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Effectiveness of Agomelatine on Quality of Life in Patients With Depression Episode Occurred After COVID-19 Assessed by SF-36 Questionnaire After 8 Weeks of Treatment of Patients Included in the Study. | The Short Form (36) Health Survey (SF36 ) scale questioner was used. SF36 is is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Tolerability of Agomelatine After 8 Weeks of Treatment Based on Rate of Adverse Events Leading to Drug Discontinuation in Patients Included in the Study. | Number of adverse events/ adverse drug reactions leading to drug discontinuation during the observational period. | Posted | Count of Participants | Participants | 8 weeks |
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| 103 |
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| 103 |
| 1 |
| 103 |
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| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |