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Study of Duloxetine in Elderly Patients With Major Depressive Disorder

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00062673
  Purpose

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


Condition Intervention Phase
Depression
Cognition
Drug: Duloxetine
Drug: Placebo
Phase III

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Duloxetine    Duloxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Duloxetine Versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment:   311
Study Start Date:   March 2003
Study Completion Date:   July 2004

Detailed Description:

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

  Eligibility
Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062673

Locations
United States, Wisconsin
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

Sponsors and Collaborators
Eli Lilly and Company

Investigators
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    
  More Information


Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Study ID Numbers:   6091, F1J-MC-HMBV
First Received:   June 10, 2003
Last Updated:   May 17, 2007
ClinicalTrials.gov Identifier:   NCT00062673
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Dopamine
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Serotonin
Duloxetine
Behavioral Symptoms

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 07, 2008




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