DepressionTELESPHORNCT05323994
Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression After SARS-CoV-2 (TELESPHOR)
An observational study of Depression and COVID-19, run by Servier Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, COVID-19
- How many people
- 104 participants
- Where
- 1 siteRussia
- Study dates
- 19 Apr 2022to 15 Mar 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with depression occurred after COVID 19
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia"
Moscow
About this study
Official title: Description of the Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression Occurred After SARS-CoV-2 Infection in the Daily Clinical Practice in Russia (TELESPHOR)
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.
Read the 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:
- Inclusion Visit 0 (V0) - inclusion in the study
- Follow up Visits 1-2 (V1-V2) - visits at week 2 and week 4 after V0.
- Final Visit 3 (V3) - visit at week 8 after V0.
- Conditions
- Depression, COVID-19
- Medical subject headings
- Depression, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 8 weeks
Secondary outcomes (4)
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
- Subjective tension and irritability
- Worrying about minor matters
- Apprehensive attitude apparent in face or speech
- Fears expressed without questioning
Assessment of the severity in item 11:
0- Absent
- Mild
- Moderate
- Severe
- Incapacitating
Measured: 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
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start19 Apr 2022
- Primary completion20 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323994
- Sponsor's protocol ID
- IC4-20098-069-RUS
- Acronym
- TELESPHOR
- Status last verified
- Oct 2024
- First submitted
- 8 Apr 2022
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression Occurred After SARS-CoV-2 Infection in the Daily Clinical Practice in Russia (TELESPHOR)
- ClinicalTrials.gov ID
- NCT05323994
- Acronym / sponsor ID
- TELESPHOR / IC4-20098-069-RUS
- Conditions
- Depression, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Inclusion Visit 0 (V0) - inclusion in the study
- Follow up Visits 1-2 (V1-V2) - visits at week 2 and week 4 after V0.
- Final Visit 3 (V3) - visit at week 8 after V0.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with depression occurred after COVID 19
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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"
4 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and COVID-19, run by Servier Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.