BACKGROUND: To date, the efficacy of sertraline in treating depression in the context of human immunodeficiency virus (HIV) has not been investigated, despite the agent's advantageous side effect profile, low toxicity with overdose, and lack of adverse effect on the cardiovascular system. This 8-week open trial addresses the efficacy of sertraline in the treatment of depressed HIV-infected persons, as well as its toleration and effects on immune status (T cells and natural killer cells). METHOD:Eligibility criteria included a DSM-III-R diagnosis of major depression; among the exclusion criteria were substance abuse, dementia, and severe gastrointestinal complaints. Major outcome variables included the Hamilton Rating Scale for Depression, the Clinical Global Impressions scale, and laboratory tests measuring T cell subsets and natural killer cells. RESULTS:Twenty-seven gay men and 1 woman entered treatment; 20 completed 8 weeks. Fourteen (70%) of the completers were rated responders. Five of the 8 dropouts (18% of the total sample) discontinued treatment due to side effects. Responders improved significantly on all measures of psychiatric distress as well as quality of life. Those with advanced immunosuppression (CD4 cell count < 200/cu mm) responded as well to treatment as did the others. All T cell subsets, including CD4 cell count, and natural killer cell counts (CD56 and CD57) showed no significant change from baseline to study endpoint, an average of 17 weeks later. CONCLUSION: In this small open trial, sertraline was an effective treatment for depression, displayed no apparent adverse effects on immune status, and was generally well tolerated; however, a randomized placebo-controlled study with a larger, more diverse sample is needed to confirm our results.
RCT Entities:
BACKGROUND: To date, the efficacy of sertraline in treating depression in the context of human immunodeficiency virus (HIV) has not been investigated, despite the agent's advantageous side effect profile, low toxicity with overdose, and lack of adverse effect on the cardiovascular system. This 8-week open trial addresses the efficacy of sertraline in the treatment of depressed HIV-infectedpersons, as well as its toleration and effects on immune status (T cells and natural killer cells). METHOD: Eligibility criteria included a DSM-III-R diagnosis of major depression; among the exclusion criteria were substance abuse, dementia, and severe gastrointestinal complaints. Major outcome variables included the Hamilton Rating Scale for Depression, the Clinical Global Impressions scale, and laboratory tests measuring T cell subsets and natural killer cells. RESULTS: Twenty-seven gay men and 1 woman entered treatment; 20 completed 8 weeks. Fourteen (70%) of the completers were rated responders. Five of the 8 dropouts (18% of the total sample) discontinued treatment due to side effects. Responders improved significantly on all measures of psychiatric distress as well as quality of life. Those with advanced immunosuppression (CD4 cell count < 200/cu mm) responded as well to treatment as did the others. All T cell subsets, including CD4 cell count, and natural killer cell counts (CD56 and CD57) showed no significant change from baseline to study endpoint, an average of 17 weeks later. CONCLUSION: In this small open trial, sertraline was an effective treatment for depression, displayed no apparent adverse effects on immune status, and was generally well tolerated; however, a randomized placebo-controlled study with a larger, more diverse sample is needed to confirm our results.
Authors: Jon C Mills; Jeffrey S Harman; Robert L Cook; Nicole M Marlow; Christopher A Harle; R Paul Duncan; Bradley N Gaynes; Brian W Pence Journal: AIDS Date: 2017-11-28 Impact factor: 4.177