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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