Overview

This trial is active, not recruiting.

Conditions depression, hiv, aids
Treatments escitalopram, placebo
Sponsor University of Pennsylvania
Start date January 2016
End date January 2022
Trial size 180 participants
Trial identifier NCT02620150, 823405

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, not currently on treatment for depression. Subjects will complete 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
escitalopram
10 week trial
(Placebo Comparator)
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.
placebo
10 week trial

Primary Outcomes

Measure
SSRI Effects on Change of Natural Killer Cell Activity (LUNK), Determined by Biological Assay, Units are LU20 PBMC and LU20 NK .
time frame: 10 weeks
SSRI Effects on Change of Intracellular Interferon Gamma (IFN-g), Determined by Biological Assay, (% of Natural Killer Cells producing IFN-g).
time frame: 2 weeks, 4 weeks, 10 weeks
SSRI Effects on Change of Plasma Interleukin 6 (IL-6), Determined by Biological Assay, pg/mL.
time frame: 2 weeks, 4 weeks, 10 weeks
SSRI Effects on Change of Plasma C-Reactive Protein (CRP), Determined by Biological Assay, (mg/L).
time frame: 2 weeks, 4 weeks, 10 weeks

Secondary Outcomes

Measure
Depression Improvement Effects on Change of Natural Killer Cell Activity (LUNK), Determined by Biological Assay, Units are LU20 PBMC and LU20 NK.
time frame: 10 weeks
Depression Improvement Effects on Change of Intracellular Interferon Gamma (IFN-g), Determined by Biological Assay, (% of Natural Killer Cells producing IFN-g).
time frame: 2 weeks, 4 weeks, 10 weeks
Depression Improvement Effects on Change of Plasma Interleukin 6 (IL-6), Determined by Biological assay, (pg/mL).
time frame: 2 weeks, 4 weeks, 10 weeks
Depression Improvement Effects on Change of Plasma C-Reactive Protein (CRP), Determined by Biological Assay, (mg/L).
time frame: 2 weeks, 4 weeks, 10 weeks

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

Inclusion Criteria: 1. Men and women aged 18-64 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 40 copies/ml, 5. Current depressive symptoms (HAM-D-17 score equal or greater than 13), and a SCID diagnosis of Major Depressive Disorder, 6. Able to understand and provide informed consent. Exclusion Criteria: 1. Acute and marked suicidal ideation or intent, 2. Significant cognitive impairment or dementia, 3. Use of a medication known to alter immune function within 4 weeks prior to enrollment, 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, 9. History of bipolar disorder (I or II) or schizophrenia, 10. Current pharmacotherapy and/or psychotherapy 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. Taking diuretics, 14. History of seizures or taking Carbamazepine, 15. Taken MAOIs within 14 days, 16. On the antibiotic Linezolid and taking IV methylene blue, 17. On a regular regime of medication known to have anticoagulant properties such as NSAID, aspirin or warfarin, 18. A history of acute narrow/closed angle glaucoma, 19. Currently taking CNS drugs, 20. On any triptan medications, 21. Undergoing ECT.

Additional Information

Official title SSRI Effects on Depression and Immunity in HIV/AIDS
Principal investigator Dwight L Evans, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.