A double blind, placebo-controlled pilot study of galantamine augmentation of antidepressant treatment in older adults with major depression

• Authors: Paul Holtzheimer, Emory University; Thomas W. Meeks, Emory University; Mary Kelley, Emory University; Mustafa Mufti, Emory University; Raymond Young, Emory University; Kimberly McWhorter, Emory University; Nancie Vito, Emory University; Ronald Chismar, Emory University; Sinead Quinn, Emory University; Sherry Dey, Emory University; Eve H Byrd, Emory University; William M. McDonald, Emory University
• Journal Title: International Journal of Geriatric Psychiatry
• Volume: Volume 23, Number 6
• Publisher: Wiley: 12 months | 2008-06-01, Pages 625-631
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1002/gps.1951
• Subjects: Health Sciences, Mental Health; Psychology, Clinical; Biology, Biostatistics
• Keywords: Science & Technology; Life Sciences & Biomedicine; Geriatrics & Gerontology; Gerontology; Psychiatry; late-life depression; galantamine; acetylcholinesterase inhibitors; venlafaxine; citalopram; major depression; antidepressant treatment; ALZHEIMER-DISEASE; ADJUNCTIVE DONEPEZIL; VASCULAR DEMENTIA; SCHIZOPHRENIA; BEHAVIOR; SAFETY; TRIAL; RISK

Abstract

Objective: Depression in older adults is often associated with cognitive abnormalities and may predict later development of a primary cognitive disorder. This double-blind, randomized, placebo-controlled pilot study was designed to assess the safety and efficacy of galantamine augmentation of antidepressant treatment for depressive and cognitive symptoms in older adults with major depression. Methods: Thirty-eight, non-demented older adults (age >50) with major depression were randomized to receive galantamine or placebo augmentation of standard antidepressant pharmacotherapy (venlafaxine XR or citalopram). Mood and cognitive status were monitored for 24 weeks using the 24-item Hamilton Rating Scale for Depression and the Repeatable Battery for the Assessment of Neuropsychological Status. Results: Both groups showed significant improvements in mood and cognition over 24 weeks, but no significant difference was found in change over time between groups. An exploratory post-hoc analysis suggested that patients randomized to galantamine had lower depression scores compared to patients in the placebo group after 2 weeks of treatment. Dropout was high with more subjects randomized to antidepressant plus galantamine withdrawing early from the study. Conclusions: This pilot study failed to demonstrate a benefit for galantamine augmentation of antidepressant medication in the treatment of depression in older adults. Future studies should explore strategies for reducing dropout in such longitudinal trials and more carefully assess rime to response with cholinesterase inhibitor augmentation.