Duloxetine therapy for elderly patients with depression results in significant improvement in verbal learning and recall testing
Elderly patients with depression treated
with duloxetine had twice as much improvement in verbal learning
and recall testing as peers given placebo, according to a presentation
at the annual meeting of the American Association for Geriatric
Psychiatry.
By the end of the eight-week study, duloxetine
patients demonstrated significantly greater improvement in cognition
than patients treated with placebo (mean change, 1.95 vs. 0.76).
In addition, 27.4 percent of duloxetine patients were virtually
free of depressive symptoms, a rate nearly double that seen with
placebo (14.7 percent). Significant improvements in depressive symptoms
with duloxetine therapy were seen as early as one week.
It appears that impairment of cognitive functioning
is a bigger issue among elderly people with depression than younger
adults. Many older patients already show some signs of memory decline
such as forgetting the location of keys, other personal items, etc.
"Treating and diagnosing depression
in elderly patients can be complicated -- their condition presents
differently from younger patients, making it more difficult to diagnose,
and their response to medication is less predictable," stated
Alan Siegal, MD, presenter. "Depression-related cognitive impairment,
along with a greater sensitivity to medication side effects, often
make it more difficult for older patients to comply with treatment
recommendations."
"Previous clinical trials using other
antidepressants in this patient population showed cognitive dysfunction
persisted even after the depression had responded to treatment,"
explained Joel Raskin, MD, medical advisor, Eli Lilly and Company.
"In this study, significant improvements in both cognition
and depression were seen."
Data were gathered from 311 patients aged
65 and older who participated in a multicenter, double-blind, placebo-controlled
study. After a one-week screening and a one-week, double-blind placebo
phase, patients were randomly chosen to receive either duloxetine
60 mg once daily (n=207) or a sugar pill (n=104) for eight weeks.
Patients then entered a one-week, double-blind
discontinuation phase where the dose of the study medication was
tapered.
The primary outcome measure was a composite
cognitive score based on four tests that measured verbal learning
and memory, selective attention and executive functioning. Secondary
measures included the Geriatric Depression Scale and the Hamilton
Depression Scale (HAMD17). Response in depression symptoms at endpoint
was defined as a greater than 50 percent decrease in the HAMD17
Total Score from baseline. Remission of depression symptoms at endpoint
was defined as a HAMD17 Total Score of less than 7.
Based on preclinical data, duloxetine is
a balanced and potent reuptake inhibitor of serotonin and norepinephrine.
It is indicated in the United States for the treatment of major
depression and management of diabetic peripheral neuropathic pain.
The European Commission has also approved duloxetine for the treatment
of major depression and moderate-to-severe stress urinary incontinence
in adults.
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