BACKGROUND: When present, depression in the context of human immunodeficiency virus (HIV) illness not only detracts from quality of remaining life but may interfere with motivation to obtain good medical care as well, thus directly influencing life's duration. This study was undertaken to assess the efficacy of fluoxetine in treating depression occurring in the context of HIV illness and to assess effects, if any, of fluoxetine on immune status (T-cell subsets). METHOD: Patients had originally participated in a double-blind, placebo-controlled, 6-week study of imipramine. Imipramine nonresponders or relapsers and side effect dropouts were offered open treatment with fluoxetine for 12 weeks. Adjunctive dextroamphetamine was prescribed if the treating psychiatrist considered it clinically indicated. Eligibility criteria for the original study included a DSM-III-R diagnosis of major depression, dysthymia, or both. Concurrent HIV medications were permitted. RESULTS: Measures included the clinician-rated Hamilton Rating Scale for Depression and Clinical Global Impressions Scale, and patient-rated Brief Symptom Inventory and Beck Hopelessness Scale. Of the 23 patients receiving onlyfluoxetine, 83% (N = 19) were classified as responders. Of the 7 (30%) who also received adjunctive dextroamphetamine, all responded. Patients with CD4 cell counts under 200/cu mm did as well as others. CD4 cell count was not influenced by duration of treatment with fluoxetine; the average decline was that expected due to the passage of time alone. Side effects were mild and relatively infrequent. CONCLUSION: In this open treatment study, fluoxetine alone and fluoxetine plus dextroamphetamine were found to be effective treatments for patients with HIV illness and Axis I depression, regardless of the initial level of immune deficiency or number or type of HIV medications used concurrently. No negative effects on immune status were observed.
RCT Entities:
BACKGROUND: When present, depression in the context of human immunodeficiency virus (HIV) illness not only detracts from quality of remaining life but may interfere with motivation to obtain good medical care as well, thus directly influencing life's duration. This study was undertaken to assess the efficacy of fluoxetine in treating depression occurring in the context of HIV illness and to assess effects, if any, of fluoxetine on immune status (T-cell subsets). METHOD:Patients had originally participated in a double-blind, placebo-controlled, 6-week study of imipramine. Imipramine nonresponders or relapsers and side effect dropouts were offered open treatment with fluoxetine for 12 weeks. Adjunctive dextroamphetamine was prescribed if the treating psychiatrist considered it clinically indicated. Eligibility criteria for the original study included a DSM-III-R diagnosis of major depression, dysthymia, or both. Concurrent HIV medications were permitted. RESULTS: Measures included the clinician-rated Hamilton Rating Scale for Depression and Clinical Global Impressions Scale, and patient-rated Brief Symptom Inventory and Beck Hopelessness Scale. Of the 23 patients receiving only fluoxetine, 83% (N = 19) were classified as responders. Of the 7 (30%) who also received adjunctive dextroamphetamine, all responded. Patients with CD4 cell counts under 200/cu mm did as well as others. CD4 cell count was not influenced by duration of treatment with fluoxetine; the average decline was that expected due to the passage of time alone. Side effects were mild and relatively infrequent. CONCLUSION: In this open treatment study, fluoxetine alone and fluoxetine plus dextroamphetamine were found to be effective treatments for patients with HIV illness and Axis I depression, regardless of the initial level of immune deficiency or number or type of HIV medications used concurrently. No negative effects on immune status were observed.