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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT01655706
Eligibility Criteria:
For Depressed patients:
Inclusion Criteria:
* Outpatients who are 18-60 years of age
* Meet DSM-IV-TR criteria for Major Depressive Episode in Major Depressive Disorder by the MINI
* Episode duration ≥ 3 months
* Free of psychotropic medications for at least 5 half-lives (i.e. 1 week for most antidepressants, 5 weeks for fluoxetine) before baseline Visit 1
* MADRS ≥ 24
* Fluency in English, sufficient to complete the interviews and self-report questionnaires
Exclusion Criteria:
* Any Axis I diagnosis other than MDD that is considered the primary diagnosis
* Bipolar I or Bipolar II diagnosis
* Presence of a significant Axis II diagnosis (borderline, antisocial)
* High suicidal risk, defined by clinician judgment
* Substance dependence/abuse in the past 6 months
* Presence of significant neurological disorders, head trauma or other unstable medical conditions
* Pregnant or breastfeeding
* Failure of 3 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form)
* Started psychological treatment within the past 3 months with the intent of continuing treatment
* Patients who have previously failed escitalopram or showed intolerance to escitalopram and patients at risk for hypomanic switch (i.e. with a history of antidepressant hypomania)
Inclusion criteria for Healthy Controls:
* 18 to 60 years of age
* No history of Axis I or Axis II disorders, as determined by the MINI.
* Fluency in English, sufficient to complete the interviews and self-report questionnaires.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01655706
Study Brief:
Protocol Section:
NCT01655706