Trial Outcomes & Findings for Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression After SARS-CoV-2 (TELESPHOR) (NCT NCT05323994)
NCT ID: NCT05323994
Last Updated: 2024-10-17
Results Overview
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"
COMPLETED
104 participants
8 weeks
2024-10-17
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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104
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Overall Study
COMPLETED
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103
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Protocol Violation
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With Depression Occurred After COVID 19
n=103 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=103 Participants
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Age, Categorical
Between 18 and 65 years
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103 Participants
n=103 Participants
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Age, Categorical
>=65 years
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0 Participants
n=103 Participants
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Age, Continuous
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44 years
STANDARD_DEVIATION 13.31 • n=103 Participants
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Sex: Female, Male
Female
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73 Participants
n=103 Participants
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Sex: Female, Male
Male
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30 Participants
n=103 Participants
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Region of Enrollment
Russia
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103 Participants
n=103 Participants
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PRIMARY outcome
Timeframe: 8 weeksMean 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"
Outcome measures
| Measure |
Patients With Depression Occurred After COVID 19
n=103 Participants
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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|---|---|
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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.
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10.9 score on a scale
Standard Deviation 4.90
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SECONDARY outcome
Timeframe: 8 weeksMean 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
Outcome measures
| Measure |
Patients With Depression Occurred After COVID 19
n=103 Participants
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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|---|---|
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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
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0.5 score on a scale
Standard Deviation 0.61
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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
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0.6 score on a scale
Standard Deviation 0.56
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SECONDARY outcome
Timeframe: 8 weeksThe 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
Outcome measures
| Measure |
Patients With Depression Occurred After COVID 19
n=103 Participants
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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|---|---|
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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.
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1.3 score on a scale
Standard Deviation 0.64
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SECONDARY outcome
Timeframe: 8 weeksThe 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.
Outcome measures
| Measure |
Patients With Depression Occurred After COVID 19
n=103 Participants
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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|---|---|
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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
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50.5 score on a scale
Standard Deviation 5.70
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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
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58.7 score on a scale
Standard Deviation 6.91
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SECONDARY outcome
Timeframe: 8 weeksNumber of adverse events/ adverse drug reactions leading to drug discontinuation during the observational period.
Outcome measures
| Measure |
Patients With Depression Occurred After COVID 19
n=103 Participants
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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|---|---|
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Tolerability of Agomelatine After 8 Weeks of Treatment Based on Rate of Adverse Events Leading to Drug Discontinuation in Patients Included in the Study.
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1 Participants
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Adverse Events
Patients With Depression Occurred After COVID 19
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients With Depression Occurred After COVID 19
n=103 participants at risk
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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|---|---|
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Psychiatric disorders
inefficiency of treatment
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0.97%
1/103 • Number of events 1 • 8 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place