• To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Verbal Learning & Recall Test (VLRT)
• To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Symbol Digit Substitution Test (SDST)
• To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from 2-Digit Cancellation Test (2DCT)
• To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Letter-Number Sequencing Test (LNST)

• To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the Geriatric Depression Scale (GDS)
• To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the 17-item Hamilton Depression Rating Scale (HAMD17) total score
• To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by response and remission rates
• To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the Clinical Global Impressions of Severity Scale (CGI Severity) and the HAMD17 subscale scores
• To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on the painful physical symptoms of depression, as measured by the Visual Analog Scale for pain (VAS)
• To compare the safety of duloxetine 60 mg QD and placebo using information on vital signs, electrocardiograms (ECGs), treatment-emergent adverse events, discontinuation-emergent adverse events, discontinuation rates and laboratory analyses
• To assess the impact of treatment with duloxetine 60 mg QD and placebo on quality of life as measured by the Short-Form (SF-36) Health Survey

A study of the safety and efficacy of duloxetine in elderly patients (greater than 65 years old) with major depressive disorder

Duloxetine 60 mg QD and placebo variable-duration, placebo lead-in period 9 weeks in the acute treatment phase

• Depression
• Cognition

• Drug: Duloxetine
• Drug: Placebo

• Raskin J, Wiltse CG, Dinkel JJ, Walker DJ, Desaiah D, Katona C. Safety and tolerability of duloxetine at 60 mg once daily in elderly patients with major depressive disorder. J Clin Psychopharmacol. 2008 Feb;28(1):32-8.
• Wise TN, Wiltse CG, Iosifescu DV, Sheridan M, Xu JY, Raskin J. The safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity. Int J Clin Pract. 2007 Aug;61(8):1283-93. Epub 2007 Jun 22.
• Raskin J, Xu JY, Kajdasz DK. Time to response for duloxetine 60 mg once daily versus placebo in elderly patients with major depressive disorder. Int Psychogeriatr. 2008 Apr;20(2):309-27. Epub 2007 Jun 22.
• Raskin J, Wiltse CG, Siegal A, Sheikh J, Xu J, Dinkel JJ, Rotz BT, Mohs RC. Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder: an 8-week, double-blind, placebo-controlled trial. Am J Psychiatry. 2007 Jun;164(6):900-9.

Inclusion Criteria:

• You must be able to visit the doctor's office for clinic visits, tests, and procedures.
• You must have been diagnosed with major depression, and have had at least one other episode in the past.

Exclusion Criteria:

• You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
• You have taken a drug within the last 30 days that has not been approved for use by governmental authorities.