N/A
Completed N=104
Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression After SARS-CoV-2 (TELESPHOR)
Source: ClinicalTrials.gov NCT05323994 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: 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. — 10.9 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
10.9 | — |
| SECONDARY 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. |
0.5; 0.6 | — |
| SECONDARY 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. |
1.3 | — |
| SECONDARY 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. |
50.5; 58.7 | — |
| SECONDARY Tolerability of Agomelatine After 8 Weeks of Treatment Based on Rate of Adverse Events Leading to Drug Discontinuation in Patients Included in the Study. |
1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05323994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.