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 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT02620150
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged 18-70 years, of any race and ethnicity,
2. HIV-seropositive by ELISA and Western Blot assays, infected by behavioral transmission (perinatal HIV excluded),
3. Willing and able to comply with antidepressant medication regimen and scheduled follow-up visits,
4. Currently on a documented regimen of cART for at least 3 months and Viral load less than 200 copies/ml,
5. Current depressive symptoms (HAM-D-17 score ≥ 13 and a SCID diagnosis of either Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), Unspecified Depressive Disorder, or Other Specified Depressive Disorder)
6. Able to understand and provide informed consent.
Exclusion Criteria:
1. Acute suicidal ideation, gestures, or attempts (e.g., HAM-D suicide item score of 3 "Ideas or gestures of suicide" or 4 "Attempts at suicide" at intake or HAM-D suicide item score of 4 "Attempts at suicide" during study),
2. Significant cognitive impairment or dementia including HIV Associated Dementia (HAD),
3. Use of a medication known to alter immune function within 4 weeks prior to randomization (the following are not excluded: a. acyclovir and related antiviral medications, b. topical corticosteroids, c. corticosteroid nasal sprays or inhalers, d) statin medications,),
4. Immunization with HIV vaccine,
5. Presence of psychotic symptoms or known diagnosis of a primary psychotic disorder,
6. Currently taking an anti-psychotic medication,
7. Pregnant or within nine months post-delivery, lactation,
8. Current or chronic medical condition that would likely preclude adherence to protocol or completion of the trial (per investigator judgment),
9. Bipolar disorder (I or II) or schizophrenia,
10. Current pharmacotherapy for treatment of depression,
11. A history of intolerance or nonresponse to an adequate trial of escitalopram (or other SSRIs),
12. Renal failure, including those who require dialysis,
13. History of epilepsy or seizure disorder,
14. Taken MAOIs within 14 days,
15. On the antibiotic Linezolid and taking IV methylene blue,
16. On a regular regime of medication known to have anticoagulant properties such as NSAID, aspirin or warfarin,
17. A history of acute narrow/closed angle glaucoma,
18. Currently taking CNS drugs (the following are not excluded: gabapentin, pregabalin, varenicline, antihistamines, and hypnotics (e.g. zolpidem, zaleplon, eszopiclone),
19. On any triptan medications,
20. Undergoing ECT.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02620150
Study Brief:
Protocol Section:
NCT02620150