A Phase 4 interventional study of Escitalopram and Placebo in Depression, HIV and AIDS, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment
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.
To pursue our long-term objective of successfully treating co-morbid mental and medical disorders in HIV/AIDS, this study aims to determine whether: 1) SSRI treatment significantly increases innate immunity and decreases chronic inflammation and immune activation, and 2) changes in depressive symptoms correlate with changes in immunity in HIV/AIDS.
HIV-seropositive, depressed subjects will be randomized to 10 weeks of double blind therapy with either escitalopram or placebo. All participants will concurrently begin CCBT (Computerized Cognitive Behavioral Therapy) using the program Good Days Ahead.
Subject visits will occur weekly for the first 6 weeks and then at weeks 8 and 10. The treating clinician will assess side effects, review symptomatic progress, and adjust the study medication as clinically appropriate. An independent clinical evaluator will assess patients at baseline, and weeks 1-6, 8 and 10. Blood samples collected at baseline and weeks 2, 4, and 10 will be used to assay markers of innate immune suppression (lytic units of NK cells, LUNK, and intracellular IFN gamma in NK cells) and markers of inflammation (IL-6 and C-Reactive Protein). At the end of the 10-week treatment phase, all participants will be referred for appropriate clinical treatment of their depression.
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This study's enrollment of 108 is above the median of 84 across 6,718 interventional studies indexed under Depression.
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Exclusion Criteria:
CCBT plus Escitalopram, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Drug: Escitalopram
CCBT plus Placebo, oral, for 10 weeks, once daily, starting at 10mg/day. Tapered up or down, based on tolerability and clinical response, to 20mg/day max.
Other: Placebo
10 week trial
10 week trial
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.]
The outcome was determined by biological assays. Natural killer cells (NK cells) are white blood cells, a type of lymphocytes, that destroy infected and cancer cells through antigen independent recognition. Higher numbers indicate higher levels of cytotoxicity, that is, stronger cellular response. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
Time frame: Post randomization to 10 weeks
Percent of Natural Killer (NK) Cells Producing Intracellular Interferon Gamma (IFN-g)
The outcome was determined by biological assays, which determined the number of NK cells, and the number of these cells that produced IFN-g, and combined these to calculate the outcome. Higher numbers are associated with stronger cellular response. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
Time frame: Post randomization to 10 weeks
Units of Concentration of Plasma Interleukin 6 (IL-6), Expressed as Picograms Per Milliliter
The outcome was determined by biological assays, which determined the concentration of IL-6, expressed as pg/ml. Higher concentrations indicate greater inflammation. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
Time frame: Post randomization to 10 weeks
Units of Concentration of Plasma C-Reactive Protein (CRP), Expressed as Milligrams Per Liter
The outcome was determined by biological assays, which determined the concentration of CRP, expressed as mg/l. Higher concentrations indicate greater inflammation. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
Time frame: Post randomization to 10 weeks
Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Natural Killer Cell Activity
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on Natural killer cell activity.
Time frame: 10 weeks
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)
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on the Percent of Natural Killer (NK) Cells Producing Intracellular Interferon Gamma (IFN-g)
Time frame: 10 weeks
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
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on Units of Concentration of Plasma Interleukin 6 (IL-6)
Time frame: 10 weeks
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
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on Units of Concentration of Plasma C-Reactive Protein (CRP)
Time frame: 10 weeks
| Milestone | Experimental | Placebo |
|---|---|---|
| Started | 55 | 53 |
| Completed | 48 | 50 |
| Not completed | 7 | 3 |
The outcome was determined by biological assays. Natural killer cells (NK cells) are white blood cells, a type of lymphocytes, that destroy infected and cancer cells through antigen independent recognition. Higher numbers indicate higher levels of cytotoxicity, that is, stronger cellular response. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
| Lytic Units | Experimental | Placebo |
|---|---|---|
| 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 (155.81 to 358.33) | 252.02 (150.16 to 360.28) |
The outcome was determined by biological assays, which determined the number of NK cells, and the number of these cells that produced IFN-g, and combined these to calculate the outcome. Higher numbers are associated with stronger cellular response. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
| Percentage of NK cells producing IFN-g | Experimental | Placebo |
|---|---|---|
| Percent of Natural Killer (NK) Cells Producing Intracellular Interferon Gamma (IFN-g) | 8.25 (3.50 to 16.00) | 5.40 (3.00 to 11.20) |
The outcome was determined by biological assays, which determined the concentration of IL-6, expressed as pg/ml. Higher concentrations indicate greater inflammation. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
| Concentration of IL-6 (pcg/mL) | Experimental | Placebo |
|---|---|---|
| Units of Concentration of Plasma Interleukin 6 (IL-6), Expressed as Picograms Per Milliliter | 2.52 (1.57 to 3.71) | 3.17 (2.21 to 4.64) |
The outcome was determined by biological assays, which determined the concentration of CRP, expressed as mg/l. Higher concentrations indicate greater inflammation. In the present summaries, we calculated the within-participant median value of the outcome over their available data at weeks 2, 4 and 10, and obtained overall and within-group summaries for these within-participant distributions.
| Concentration of CRP (mg / l) | Experimental | Placebo |
|---|---|---|
| Units of Concentration of Plasma C-Reactive Protein (CRP), Expressed as Milligrams Per Liter | 3.75 (1.52 to 5.97) | 3.17 (2.21 to 4.64) |
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on Natural killer cell activity.
| Correlation coefficient | Experimental | Placebo |
|---|---|---|
| Correlation Between Change in Overall Score on the Hamilton Depression Rating Scale, and Change in Natural Killer Cell Activity | 0.24 | -0.28 |
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on the Percent of Natural Killer (NK) Cells Producing Intracellular Interferon Gamma (IFN-g)
| Correlation coefficient | Experimental | Placebo |
|---|---|---|
| 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 |
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on Units of Concentration of Plasma Interleukin 6 (IL-6)
| Correlation coefficient | Experimental | Placebo |
|---|---|---|
| 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 |
The outcome was determined by calculating the Spearman correlation between decrease in overall score on the Hamilton Depression Rating Scale and decrease on Units of Concentration of Plasma C-Reactive Protein (CRP)
| Correlation coefficient | Experimental | Placebo |
|---|---|---|
| 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 |
Collected over 10 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 1/55 (1.8%) | 2/55 (3.6%) | 33/55 (60%) |
| Placebo | 0/53 (0%) | 1/53 (1.9%) | 36/53 (67.9%) |
| Event | Experimental | Placebo |
|---|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/55 | 1/53 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/55 | 1/53 |
| Death due to fentanyl/cocaineInjury, poisoning and procedural complications | 1/55 | 0/53 |
| StrokeNervous system disorders | 1/55 | 0/53 |
| Event | Experimental | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 11/55 | 7/53 |
| DiarrheaGastrointestinal disorders | 5/55 | 7/53 |
| PainGeneral disorders | 6/55 | 6/53 |
| Worsening Psychiatric SymptomsPsychiatric disorders | 2/55 | 6/53 |
| SinusitisRespiratory, thoracic and mediastinal disorders | 1/55 | 6/53 |
| InsomniaPsychiatric disorders | 4/55 | 5/53 |
| Influenza-like symptomsGeneral disorders | 1/55 | 5/53 |
| SomnolencePsychiatric disorders | 4/55 | 4/53 |
| HeadacheNervous system disorders | 3/55 | 4/53 |
| Sexual DysfunctionGeneral disorders | 4/55 | 3/53 |
| Age, Continuous(years) | Experimental | Placebo | Total |
|---|---|---|---|
| Mean | 49.95 ± 11.99 | 49.87 ± 10.97 | 49.91 ± 11.45 |
| Sex/Gender, Customized(Participants) | Experimental | Placebo | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 34 | 32 | 66 |
| Transgender Female | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Experimental | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 7 | 11 |
| Not Hispanic or Latino | 50 | 46 | 96 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Experimental | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 49 | 47 | 96 |
| White | 5 | 4 | 9 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Overall Score on the Hamilton Depression Rating Scale(units on a scale) | Experimental | Placebo | Total |
|---|---|---|---|
| Mean | 19.13 ± 4.90 | 19.21 ± 5.07 | 19.17 ± 4.96 |
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University of Pennsylvania