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

Depression Clinical Trial

— TELESPHOR  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323994
• Other study ID #: IC4-20098-069-RUS
• Status: Recruiting
• Start date: April 19, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2023
• Source: Servier Russia
• Contact: Denis Morozov
• Phone: +7 495 9370700
• Email: denis.morozov[@]servier.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Depression
• Depressive Disorder

Locations

Country	Name	City	State
Russian Federation	Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia"	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.		8 weeks
Secondary	Effectiveness of agomelatine on anxiety symptoms assotiated with the depression and assessed by HAMD-17 (point 10 and 11) after 8 weeks of treatment of patients included in the study.		8 weeks
Secondary	Effectiveness of agomelatine on global improvement and social functioning assessed by CGI score after 8 weeks of treatment of patients included in the study.		8 weeks
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.		8 weeks
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.		8 weeks