Study of Duloxetine in Elderly Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00062673
First received: June 10, 2003
Last updated: May 17, 2007
Last verified: May 2007

June 10, 2003
May 17, 2007
March 2003
Not Provided
  • 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)
Not Provided
Complete list of historical versions of study NCT00062673 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
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Study of Duloxetine in Elderly Patients With Major Depressive Disorder
Duloxetine Versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Depression
  • Cognition
  • Drug: Duloxetine
  • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
311
July 2004
Not Provided

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00062673
6091, F1J-MC-HMBV
No
Not Provided
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP