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:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT06796868
Eligibility Criteria:
Inclusion Criteria:
* Outpatients aged 18 to 65 years (including both limits), either male or female;
* Meet the diagnostic criteria for depression in DSM-5 (the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders), without psychotic symptoms;
* Have a total score of ≥ 22 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at both screening and baseline visits;
* Have a Clinical Global Impression - Severity (CGI-S) score of ≥ 4 at both screening and baseline visits;
* Voluntarily participate in this trial and sign the informed consent form, and be able to comply with the planned visits, treatment plan, laboratory tests and other research procedures.
Exclusion Criteria:
* Allergic constitution (such as those allergic to two or more drugs or foods) or known to be allergic to similar products like agomelatine;
* Have previously received adequate and full-course treatment with agomelatine but showed no effect, or treatment-resistant depression (those who have used at least two antidepressants in adequate and full-course treatment but still showed no effect);
* HAM-D17 scale score reduction rate is ≥25% compared to the baseline period;
* High suicide risk; history of suicide attempts within one year before screening; suicidal or self-harming behavior during the screening period; score of ≥3 on item 3 (suicide item) of the HAM-D17 scale;
* Diagnosed with any disease other than depression according to DSM-5, including anxiety disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, trauma and stress-related disorders, dissociative disorders, anorexia or bulimia nervosa, personality disorders, etc.;
* Depression secondary to other mental or physical diseases. Note: Other inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06796868
Study Brief:
Protocol Section:
NCT06796868