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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT01198795
Eligibility Criteria:
Inclusion Criteria:
* Male or female outpatients 7 to 11 years of age, inclusive
* Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks
* Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits)
* Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring
Exclusion Criteria:
* Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment
* Patients with a diagnosis of conduct disorder will not be allowed to participate in this study
* Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria
* History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class
* Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
* Suicide risk as determined by meeting any of the following criteria:
* Any suicide attempt
* Significant risk, as judged by the PI, based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
11 Years
Study:
NCT01198795
Study Brief:
Protocol Section:
NCT01198795