Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05323994
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05323994
Study Brief:
Protocol Section:
NCT05323994