SSRI Effects on Depression and Immunity in HIV/AIDS

Completed · Phase 4 · Has a placebo group

Conditions studied: Depression, HIV, AIDS

In brief

This is a 10 week, double-blind, placebo controlled trial to evaluate SSRI (Selective Serotonin Reuptake Inhibitor) effects for treatment of depression in HIV/AIDS with a focus on innate immunity and inflammation. Depressed population is HIV + on cART (Combination Antiretroviral Therapy), not currently on pharmacotherapy for depression. Subjects will complete computerized cognitive behavior therapy, CCBT for their depression. Blood samples collected for virologic, neuroendocrine, and immunologic evaluation. Our overarching hypothesis is that SSRI treatment of depression and improvement of depressive symptoms leads to increased innate immunity and decreased inflammation, resulting in better control of HIV disease and decreased morbidity.

Key facts

Study ID: NCT02620150
Run by: University of Pennsylvania
People needed: 108
Starts: 2017-02-16
Expected to finish: 2022-03-31
Last updated by the study team: 2024-05-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women aged 18-70 years, of any race and ethnicity,
HIV-seropositive by ELISA and Western Blot assays, infected by behavioral transmission (perinatal HIV excluded),
Willing and able to comply with antidepressant medication regimen and scheduled follow-up visits,
Currently on a documented regimen of cART for at least 3 months and Viral load less than 200 copies/ml,
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)
Able to understand and provide informed consent.

You may not qualify if…

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),
Significant cognitive impairment or dementia including HIV Associated Dementia (HAD),
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,),
Immunization with HIV vaccine,
Presence of psychotic symptoms or known diagnosis of a primary psychotic disorder,
Currently taking an anti-psychotic medication,
Pregnant or within nine months post-delivery, lactation,
Current or chronic medical condition that would likely preclude adherence to protocol or completion of the trial (per investigator judgment),
Bipolar disorder (I or II) or schizophrenia,
Current pharmacotherapy for treatment of depression,
A history of intolerance or nonresponse to an adequate trial of escitalopram (or other SSRIs),
Renal failure, including those who require dialysis,
History of epilepsy or seizure disorder,
Taken MAOIs within 14 days,
On the antibiotic Linezolid and taking IV methylene blue,
On a regular regime of medication known to have anticoagulant properties such as NSAID, aspirin or warfarin,
A history of acute narrow/closed angle glaucoma,
Currently taking CNS drugs (the following are not excluded: gabapentin, pregabalin, varenicline, antihistamines, and hypnotics (e.g. zolpidem, zaleplon, eszopiclone),
On any triptan medications,
Undergoing ECT.

Where it is running

University of Pennsylvania Perelman School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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