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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT05816018
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of depressive episode in Major Depressive Disorder (DSM-5);
* at least one depressive episode preceding the current one;
* aged between 18 and 65;
* score of at least 8 on the Hamilton Depression Rating Scale (HDRS);
* signature of the information form and declaration of informed consent;
* elementary school certificate (as a minimum requirement for understanding the questions presented in the tests);
* native Italian speaker (or bilingualism).
Exclusion Criteria:
* diagnosis of bipolar disorder, cyclothymic disorder, schizophrenia and other psychotic spectrum disorders, neurodevelopmental disorders;
* diagnosis of intellectual disability, epilepsy, neurodegenerative disorders;
* disorders related to the use of drugs or alcohol in the last 6 months (except nicotine and caffeine);
* pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05816018
Study Brief:
Protocol Section:
NCT05816018