Clinical trial NCT05323994: Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression After SARS-CoV-2 (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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
COVID-19
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with depression occurred after COVID 19

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: Tolerability of Agomelatine After 8 Weeks of Treatment Based on Rate of Adverse Events Leading to Drug Discontinuation in Patients Included in the Study.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia"
Study officials:
References: