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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Duloxetine Versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00062673     History of Changes
Other Study ID Numbers: 6091, F1J-MC-HMBV
Study First Received: June 10, 2003
Last Updated: May 17, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on September 16, 2014