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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT03993457
Eligibility Criteria:
Inclusion Criteria:
* Women and men ages 18-65
* Current diagnosis of Major Depressive Disorder
* Able to read, speak, and understand English
Exclusion Criteria:
* Antidepressant use within the last 8 weeks
* Active infection or uncontrolled autoimmune disease
* Currently on oral corticosteroids or active immune suppressive therapy (methotrexate, cyclosporine, anti-cytokines medications, etc).
* Current diagnosis of uncontrolled HIV, hepatitis C or significant immunodeficiency
* Alcohol or substance use disorder
* Positive urine drug test for illicit substances or substances used out of the context of prescription
* Cognitively unable to give informed consent
* Pregnant or breastfeeding women, women of childbearing potential who are not using an accepted means of birth control, or women with a positive urine pregnancy test
* History of seizure disorder
* Previous significant adverse reaction to escitalopram or bupropion
* History of non-response to adequate doses of escitalopram or bupropion XL
* Current use of concomitant psychotropic agents (anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, folate, l-methylfolate, s-adenosyl methionine, lithium) not on the same dose for at least four weeks prior to study entry or who do not agree to continue at the same dose during the acute phase of the study.
* Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder
* Current anorexia nervosa or bulimia nervosa
* Suicidal ideation of the degree that, in the opinion of the evaluating clinician, participation in the study would place them at significantly increased risk of suicide
* Unstable medical issues of such degree that, in the opinion of the evaluating clinician, participation in the study would place them at significant risk of a serious adverse event
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03993457
Study Brief:
Protocol Section:
NCT03993457