COVID-19, Depression
Conditions
Brief summary
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.
Detailed description
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: 1. Inclusion Visit 0 (V0) - inclusion in the study 2. Follow up Visits 1-2 (V1-V2) - visits at week 2 and week 4 after V0. 3. Final Visit 3 (V3) - visit at week 8 after V0.
Interventions
None listed
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Obtained signed informed consent from the patient. * Age of 18-65 years old. * Out-patient with confirmed COVID 19 infection within 3 months period before the date of inclusion. * Confirmed depression with total HAMD-17 score of 8-24 required treatment with antidepressive medicines. * Decision to administer agomelatine preceeds the decision to include a patient in the study.
Exclusion criteria
* Current participation in any clinical trial or during 30 day period from inclusion visit. * Suicide risk (accoding clinical evaluation of investigator). * Psychotics symptoms (according clinical evaluation of investigator). * Schizophrenia, schizo-affective disorders, organic damages of CNS, dementia, epilepsy, multiple sclerosis, Parkinson disease, Alzeimert disease, Bipolar disorders. * Alcohol abuse or drug addiction in anamnesis. * Severe or decompensated somatic or neurological disorders. * MAO inhibitors during last 2 weeks. * Treatment by others psychotropic products (antipsychotics, anxiolitics etc.). * Any contraindications to agomelatine in accordance to the local SmPC. * Patients with severe/decompensated psychiatric, somatic or neurological disorders. * Patients with any sign of liver failure (increase of transaminase up to 3 times higher), which needs to stop treatment with agomelatine. * Patients who participate in any clinical trial or survey.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 8 weeks | 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 1. Subjective tension and irritability 2. Worrying about minor matters 3. Apprehensive attitude apparent in face or speech 4. Fears expressed without questioning Assessment of the severity in item 11: 0- Absent 1. Mild 2. Moderate 3. Severe 4. Incapacitating |
| 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. | 8 weeks | 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 |
| 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. | 8 weeks | 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. |
| Tolerability of Agomelatine After 8 Weeks of Treatment Based on Rate of Adverse Events Leading to Drug Discontinuation in Patients Included in the Study. | 8 weeks | Number of adverse events/ adverse drug reactions leading to drug discontinuation during the observational period. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Patients With Depression Occurred After COVID 19 | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 103 Participants | — |
| Age, Continuous | 44 years STANDARD_DEVIATION 13.31 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 103 Participants | — |
| Sex: Female, Male Female | 73 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 103 |
| other Total, other adverse events | 1 / 103 |
| serious Total, serious adverse events | 0 / 103 |
Outcome results
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
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Depression Occurred After COVID 19 | 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. | 10.9 score on a scale | Standard Deviation 4.9 |
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 1. Subjective tension and irritability 2. Worrying about minor matters 3. Apprehensive attitude apparent in face or speech 4. Fears expressed without questioning Assessment of the severity in item 11: 0- Absent 1. Mild 2. Moderate 3. Severe 4. Incapacitating
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Depression Occurred After COVID 19 | 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. | item 10 | 0.5 score on a scale | Standard Deviation 0.61 |
| Patients With Depression Occurred After COVID 19 | 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. | item 11 | 0.6 score on a scale | Standard Deviation 0.56 |
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
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Depression Occurred After COVID 19 | 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. | 1.3 score on a scale | Standard Deviation 0.64 |
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Depression Occurred After COVID 19 | 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. | physical component | 50.5 score on a scale | Standard Deviation 5.7 |
| Patients With Depression Occurred After COVID 19 | 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. | mental component | 58.7 score on a scale | Standard Deviation 6.91 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Depression Occurred After COVID 19 | Tolerability of Agomelatine After 8 Weeks of Treatment Based on Rate of Adverse Events Leading to Drug Discontinuation in Patients Included in the Study. | 1 Participants |