Status:
COMPLETED
Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression After SARS-CoV-2 (TELESPHOR)
Lead Sponsor:
Servier Russia
Conditions:
Depression
COVID-19
Eligibility:
All Genders
18-65 years
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 clin...
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 aske...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT05323994
Start Date
April 19 2022
End Date
March 15 2023
Last Update
October 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia"
Moscow, Russia