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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT00467402
Eligibility Criteria:
Inclusion Criteria:
* Male and female adults, 18 through 70 years of age, inclusive
* Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
* A history of at least two previous episodes of Major Depression plus the current episode
* Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline
Exclusion Criteria:
* History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
* Any current Axis I disorder other than major depressive disorder which is the focus of treatment
* Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
* Use of any psychoactive medication after the screening visit
* Patients who have been previously treated with agomelatine
* Female patients of childbearing potential who are not using effective contraception
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00467402
Study Brief:
Protocol Section:
NCT00467402