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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00252356
Eligibility Criteria:
Inclusion Criteria:
Main inclusion criteria:
* 1\. Out-patients, 18 year and older.
* 2\. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria
* 3\. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
* 4\. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.
Exclusion Criteria:
Main exclusion criteria:
* 1\. Patients at immediate risk for suicidal behavior
* 2\. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset
* 3\. The duration of the current depressive episode is greater than 2 years
* 4\. Patients whose current depressive episode is secondary to a general medical condition
* 5\. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
* 6\. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
* 7\. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00252356
Study Brief:
Protocol Section:
NCT00252356