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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00917059
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-IV criteria for diagnosis of major depressive disorder (MDD) based on the Mini-International Neuropsychiatric Interview (MINI)
* Score greater than or equal to 12 on the Quick Inventory of Depressive Symptomatology - Self Rated version (QIDS-SR16)
Exclusion Criteria:
* Serious or unstable medical illness that would prevent complete participation in the trial, determined as needed from physical examination, electrocardiogram (ECG), laboratory safety tests, and review of systems
* Mentally or legally incapacitated and therefore unable to give informed consent
* Meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features
* Diagnosis of a DSM-IV axis II disorder that would interfere with completion of the protocol
* Would have met criteria for a diagnosis of drug dependency or substance abuse within the preceding 9 months
* Stable and in remission on current psychotropic medication(s)
* Has had a course of electroconvulsive therapy (ECT) within the past 6 months
* Started psychotherapy for the current depressive episode within the past 2 months
* Has experienced treatment failure with an adequate trial of any study medication during the current episode of depression or has failed to tolerate escitalopram in the current episode
* Known contraindication for use of any of the study drugs, including hyponatremia during past use of a selective serotonin reuptake inhibitor (SSRI)
* Treated with fluoxetine or a monoamine oxidase inhibitor (MAOI) within the past 4 weeks
* Presence of a serious or unstable medical illness, including heart, liver, kidney, respiratory, endocrine, neurologic, or blood disease severe enough to significantly affect brain function or to interfere with interpretation of study results
* History of seizures, brain surgery, skull fracture, significant head trauma, or abnormal electroencephalogram (EEG)
* Currently pregnant or of childbearing potential and not using a medically acceptable means of birth control (e.g., oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device \[IUD\], past tubal ligation, partner with vasectomy)
* Breastfeeding
* University student or staff member directly under instruction, supervision, or employment of any of the investigators
* Requires hospitalization (e.g., poses an imminent danger to self or others)
* Initial quantitative EEG (QEEG) is contaminated with artifact so that determination of the biomarker is precluded
* Use of medications known to affect brain function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT00917059
Study Brief:
Protocol Section:
NCT00917059