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

NCT05323994 | Completed Results

• 1 other identifier: IC4-20098-069-RUS
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; COVID-19

Outcome Measures

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.

  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

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.

  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.

  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.

  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.

  8 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with depression occurred after COVID 19

You may qualify if:

• Obtained signed informed consent from the patient.
• Age of 18-65 years old.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

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

Moscow, Russia

Location

MeSH Terms

Conditions

Depression; COVID-19

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Denis Morozov
• Organization: Sevier

denis.morozov@servier.com

8-495-93707-00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 12, 2022
• Study Start: April 19, 2022
• Primary Completion: February 20, 2023
• Study Completion: March 15, 2023
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Locations

RU (1)