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NCT Number: NCT05323994

Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression After SARS-CoV-2 (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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia"

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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"

Secondary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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.

  4. 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

    Number of adverse events/ adverse drug reactions leading to drug discontinuation during the observational period.

Sponsors and collaborators

Lead sponsor

Servier Russia

Industry

Registry information

Official study 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)

Acronym: TELESPHOR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2022
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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