Study of Duloxetine in Elderly Patients With Major Depressive Disorder

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00062673

Enrollment

311

Registered

2003-06-12

Start date

2003-03-31

Completion date

2004-07-31

Last updated

2007-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition, Depression

Brief summary

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

Detailed description

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

Interventions

DRUGDuloxetine

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the Geriatric Depression Scale (GDS)	—
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	—
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 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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026