Duloxetine Versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder
Study of Duloxetine in Elderly Patients With Major Depressive Disorder
Sponsors
Source
Eli Lilly and Company
Oversight Info
Has Dmc
No
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
Overall Status
Completed
Start Date
2003-03-01
Completion Date
2004-07-01
Primary Completion Date
N/A
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
|
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
Measure |
|
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 |
Enrollment
311
Conditions
Intervention
Eligibility
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.
Gender
All
Minimum Age
65 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
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 |
Eli Lilly and Company |
Location
Facility |
|
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 |
Location Countries
Country
United States
Verification Date
2007-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Has Expanded Access
No
Condition Browse
Secondary Id
F1J-MC-HMBV
Intervention Browse
Mesh Term
Duloxetine Hydrochloride
Firstreceived Results Date
N/A
Removed Countries
Country
Puerto Rico
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double
Study First Submitted
June 10, 2003
Study First Submitted Qc
June 11, 2003
Study First Posted
June 12, 2003
Last Update Submitted
May 17, 2007
Last Update Submitted Qc
May 17, 2007
Last Update Posted
May 21, 2007
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.