A double blind, placebo-controlled pilot study of galantamine augmentation of antidepressant treatment in older adults with major depression.
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.
Holtzheimer
Paul E
PE
Emory University School of Medicine, Atlanta, GA 30329, USA. pholtzh@emory.edu
Meeks
Thomas W
TW
Kelley
Mary E
ME
Mufti
Mustafa
M
Young
Raymond
R
McWhorter
Kimberly
K
Vito
Nancie
N
Chismar
Ronald
R
Quinn
Sinéad
S
Dey
Sherry
S
Byrd
Eve H
EH
McDonald
William M
WM
D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002800:Cholinesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D015283:Citalopram / Q000627:therapeutic use; D003511:Cyclohexanols / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005702:Galantamine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride
D000928:Antidepressive Agents; D002800:Cholinesterase Inhibitors; D003511:Cyclohexanols; D005702:Galantamine; D015283:Citalopram; D000069470:Venlafaxine Hydrochloride