Phase 4
N=108
SSRI Effects on Depression and Immunity in HIV/AIDS
Depression · HIV · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT02620150 ↗Enrolled (actual)
108
Serious AEs
2.8%
Results posted
May 2024
Primary outcome: Primary: Natural Killer Cell Activity, Measured in Lytic Units [Bryant J, Day R, Whiteside TL, and Herbeman RB: Calculation of Lytic Units for the Expression of Cell-mediated Cytotoxicity. J Immunol Methods 1992;146:91-103.] — 224.06; 252.02 Lytic Units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Escitalopram (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Natural Killer Cell Activity, Measured in Lytic Units [Bryant J, Day R, Whiteside TL, and Herbeman RB: Calculation of Lytic Units for the Expression of Cell-mediated Cytotoxicity. J Immunol Methods 1992;146:91-103.] |
224.06; 252.02 | — |
| PRIMARY Percent of Natural Killer (NK) Cells Producing Intracellular Interferon Gamma (IFN-g) |
8.25; 5.40 | — |
| PRIMARY Units of Concentration of Plasma Interleukin 6 (IL-6), Expressed as Picograms Per Milliliter |
2.52; 3.17 | — |
| PRIMARY Units of Concentration of Plasma C-Reactive Protein (CRP), Expressed as Milligrams Per Liter |
3.75; 3.17 | — |
| SECONDARY Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Natural Killer Cell Activity |
0.24; -0.28 | — |
| SECONDARY Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Percent of Natural Killer (NK) Cells Producing Intracellular Interferon Gamma (IFN-g) |
-0.01; 0.12 | — |
| SECONDARY Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Units of Concentration of Plasma Interleukin 6 (IL-6), Expressed as Picograms Per Milliliter |
-0.16; 0.16 | — |
| SECONDARY Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Units of Concentration of Plasma C-Reactive Protein (CRP), Expressed as Milligrams Per Liter |
-0.33; -0.04 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02620150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.