Back to resultsDuloxetine vs. Active Comparator for the Treatment of Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Duloxetine Hydrochloride
Venlafaxine Extended Release
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria: must be at least 18 years of age must be diagnosed with depression must sign informed consent Exclusion Criteria: women who can become pregnant must be using birth control previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder history of substance abuse or dependence in the last year patients who are suicidal frequent or severe allergic reactions with multiple medications
Sites / Locations
- 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.
Outcomes
Primary Outcome Measures
Linear measure of global benefit-risk assessment. Benefit is defined as remission at endpoint (HMAD17 total score less than or equal to 7, a virtually symptom-free state.
Secondary Outcome Measures
HAMD17 Response Rates: Response is defined as a greater or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
HAMD17 Time to First Response: Time to first response is defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.
HAMD17 Remission Rates: Remission is defined as a HAMD17 total score of less than or equal to 7 at endpoint.
Hamilton Anxiety Rating Scale (HAMA) that measures the presence and severity of anxiety. The 14-item version of this scale will be used to assess the severity of anxiety and its improvement during the course of therapy.
Clinical Global Impressions of Severity (CGI-Severity) Scale to record the severity of illness at the time of assessment.
Patient's Global Impressions of Improvement (PGI Improvement) Scale is a patient-rated instrument that measures the improvement of the patient's symptoms.
HAMD17 Subscales to evaluate severity of psychic and somatic manifestations of anxiety, as well as agitation; evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation; evaluate initial, middle and late insomnia.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00067912
Brief Title
Duloxetine vs. Active Comparator for the Treatment of Depression
Official Title
Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
How duloxetine compares to a medication currently available for the treatment of depression in the treatment of patients with major depressive disorder.
The safety of duloxetine and any side effects that might be associated with it.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Venlafaxine Extended Release
Primary Outcome Measure Information:
Title
Linear measure of global benefit-risk assessment. Benefit is defined as remission at endpoint (HMAD17 total score less than or equal to 7, a virtually symptom-free state.
Secondary Outcome Measure Information:
Title
HAMD17 Response Rates: Response is defined as a greater or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
Title
HAMD17 Time to First Response: Time to first response is defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.
Title
HAMD17 Remission Rates: Remission is defined as a HAMD17 total score of less than or equal to 7 at endpoint.
Title
Hamilton Anxiety Rating Scale (HAMA) that measures the presence and severity of anxiety. The 14-item version of this scale will be used to assess the severity of anxiety and its improvement during the course of therapy.
Title
Clinical Global Impressions of Severity (CGI-Severity) Scale to record the severity of illness at the time of assessment.
Title
Patient's Global Impressions of Improvement (PGI Improvement) Scale is a patient-rated instrument that measures the improvement of the patient's symptoms.
Title
HAMD17 Subscales to evaluate severity of psychic and somatic manifestations of anxiety, as well as agitation; evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation; evaluate initial, middle and late insomnia.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must be at least 18 years of age
must be diagnosed with depression
must sign informed consent
Exclusion Criteria:
women who can become pregnant must be using birth control
previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
history of substance abuse or dependence in the last year
patients who are suicidal
frequent or severe allergic reactions with multiple medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Calgary
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25080392
Citation
Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.
Results Reference
derived
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Duloxetine vs. Active Comparator for the Treatment of Depression
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