Study of Duloxetine in Elderly Patients With Major Depressive Disorder

Condition(s) targeted: Depression; Cognition

Intervention: Duloxetine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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

Official title: Duloxetine Versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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)

Secondary outcome:

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

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

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Middleton, Wisconsin, United States

Lilly Clinical Trial Registry

Starting date: March 2003
Ending date: July 2004
Last updated: May 17, 2007