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

Servier

Status: Enrolling

Conditions: COVID-19; Depression

Study type: Observational

Funder types: Industry

Identifiers

NCT05323994

IC4-20098-069-RUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.