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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT02082392
Eligibility Criteria:
Inclusion Criteria:
* 1\. men and women aged 18-60 years
* 2\. diagnosis with Diagnostic and Statistical Manual (DSM) IV Major Depressive Disorder (MDD)
* 3\. 24-item Hamilton Rating Scale for Depression (HRSD) score greater than or equal to 18
* 4\. capable of providing informed consent and complying with study procedures
* 5\. using appropriate contraceptive method if woman of child-bearing age
Exclusion Criteria:
* 1\. Current comorbid Axis I DSM IV disorder other than Nicotine Dependence, Adjustment Disorder, or Anxiety Disorder
* 2\. diagnosis of substance abuse or dependence (excluding Nicotine Dependence) within the past 12 months
* 3\. present or past history of psychosis, psychotic disorder, mania, or bipolar disorder
* 4\. baseline HRSD score \> 28 or HRSD suicide item \> 2
* 5\. history of allergic or adverse reaction to escitalopram, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) during the current episode
* 6\. current treatment with psychotherapy, antidepressants, antipsychotics, or mood stabilizers
* 7\. CGI-Severity score of 7 at baseline
* 8\. acute, severe, or unstable medical illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02082392
Study Brief:
Protocol Section:
NCT02082392