A double blind, placebo‐controlled pilot study of galantamine augmentation of antidepressant treatment in older adults with major depression
Open accessAbstract
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 time to response with cholinesterase inhibitor augmentation. Copyright © 2007 John Wiley & Sons, Ltd.
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Two double-blind RCTs evaluated the effects of galantamine augmentation on neurocognitive function in major depressive disorder, and both failed to demonstrate beneficial effects on cognition.
“Two double-blind, RCTs evaluated the effects of galantamine augmentation on neurocognitive function in MDD [150, 151], and both failed to demonstrate beneficial effects on cognition.”
From Cognitive remission: a novel objective for the treatment of major depression? (2016) · cites this paper as [150]
Both galantamine RCTs enrolled small samples, with the trial by Holtzheimer et al. enrolling only elderly participants.
“However, they both enrolled small samples, with that by Holtzheimer et al. [150] enrolling only elderly participants.”
From Cognitive remission: a novel objective for the treatment of major depression? (2016) · cites this paper as [150]
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- Authors
- Holtzheimer, P. E., Meeks, T. W., Kelley, M. E., Mufti, M., Young, R., McWhorter, K., Vito, N., Chismar, R., Quinn, S., Dey, S., Byrd, E. H., & McDonald, W. M.
- Affiliations
- Emory University (US)
- Corresponding author
- Holtzheimer, Paul E.
- Venue
- International Journal of Geriatric Psychiatry
- Publisher
- Wiley
- Published
- 2007-12-03
- Volume
- 23
- Issue
- 6
- Pages
- 625-631
- ISSN
- 0885-6230 (ISSN-L)
- 1099-1166
- PMC
- PMC4407281
- OpenAlex
- W1996147546
- Cited by
- 50
- References
- 28
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 3 · 2022: 1 · 2021: 4 · 2019: 2 · 2018: 5 · 2017: 3 · 2016: 7 · 2015: 2 · 2014: 4 · 2013: 1 · 2012: 5
- FWCI
- 1.33
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- International Journal of Geriatric Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- American Federation for Aging Research
- American Foundation for Suicide Prevention
- National Institute of Mental Health (K23MH077869)
- National Center for Research Resources (K12RR017643)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Physical Sciences › Chemistry › Organic Chemistry › Chemical synthesis and alkaloids
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- galantamine, antidepressant augmentation, major depressive disorder, older adults, cholinesterase inhibitors, venlafaxine, citalopram, cognitive impairment, treatment discontinuation, non-demented elderly
- MeSH terms
- Venlafaxine Hydrochloride, Aged, Antidepressive Agents, Cholinesterase Inhibitors, Cyclohexanols, Major Depressive Disorder, Double-Blind Method, Drug Therapy, Combination, Female, Galantamine, Humans, Male, Middle Aged, Neuropsychological Tests, Pilot Projects, Psychiatric Status Rating Scales, Citalopram, Treatment Outcome
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