Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-06 @ 10:05 PM
Study NCT ID:
NCT05323994
Status:
COMPLETED
Last Update Posted:
2024-10-17
First Post:
2022-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression After SARS-CoV-2 (TELESPHOR)
Sponsor:
Servier Russia
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELESPHOR
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: