NCT05323994: TELESPHOR

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

Completed Results posted Last updated 17 October 2024

What this trial tests

trial in Depression in 104 participants. Completed in 15 March 2023.

Timeline

19 April 2022

Primary endpoint
20 February 2023

15 March 2023

Quick facts

Lead sponsor	Servier Russia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	104
Start date	19 April 2022
Primary completion	20 February 2023
Estimated completion	15 March 2023
Sites	1 location across Russia

Conditions studied

• Depression — all drugs for Depression →
• COVID-19 — all drugs for COVID-19 →

Sponsor

Servier Russia — full company profile →

Who can join

Adults 18 to 65, any sex, with Depression or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 8 weeks

Mean change from baseline (BL) in total HAMD-17 (Hamilton Depression Rating Scale) score assessed at week 8 of the observational period. Assessment of the severity of condition using HAMD-17 (total score is reported, the total range from 0 to 51, where 0 score is no symptoms - 51 is for severe depression): 0 - 7 "normal" (no marked symptoms of anxiety and depression), 8 - 15 "mild depression", 16 - 24 "moderate depression", 25 - 51 "severe depression"

Group	Value	95% CI
Patients With Depression Occurred After COVID 19	10.9	± 4.90

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. Secondary · 8 weeks

Mean change from baseline (BL) in HAMD-17 (Hamilton Depression Rating Scale) in item 10 (Psychic anxiety ) and item 11 (Somatic anxiety ) after 8 weeks of treatment of patients included in the study.. Assessment of the severity in item 10: 0- No difficulty 1. Subjective tension and irritability 2. Worrying about minor matters 3. Apprehensive attitude apparent in face or speech 4. Fears expressed without questioning Assessment of the severity in item 11: 0- Absent 1. Mild 2. Moderate 3. Severe 4. Incapacitating

item 10

Group	Value	95% CI
Patients With Depression Occurred After COVID 19	0.5	± 0.61

item 11

Group	Value	95% CI
Patients With Depression Occurred After COVID 19	0.6	± 0.56

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. Secondary · 8 weeks

The clinical global impression - improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The best is - "Very much improved" - 0 scores and "Very much worse"- 6 scores - is the worest

Group	Value	95% CI
Patients With Depression Occurred After COVID 19	1.3	± 0.64

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. Secondary · 8 weeks

The Short Form (36) Health Survey (SF36 ) scale questioner was used. SF36 is is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

physical component

Group	Value	95% CI
Patients With Depression Occurred After COVID 19	50.5	± 5.70

mental component

Group	Value	95% CI
Patients With Depression Occurred After COVID 19	58.7	± 6.91

Tolerability of Agomelatine After 8 Weeks of Treatment Based on Rate of Adverse Events Leading to Drug Discontinuation in Patients Included in the Study. Secondary · 8 weeks

Number of adverse events/ adverse drug reactions leading to drug discontinuation during the observational period.

Group	Value	95% CI
Patients With Depression Occurred After COVID 19	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With Depression Occurred After COVID 19

Serious: 0/103 (0%)

Deaths: 0/103

Other adverse events (1 terms — click to expand)

Reaction	System	Patients With Depression O…
inefficiency of treatment	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT05323994 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.