Duloxetine vs. Active Comparator in the Treatment of Patients With Depression
Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder
2 other identifiers
interventional
320
1 country
1
Brief Summary
How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 depression
Started Jul 2003
Shorter than P25 for phase_4 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 29, 2003
CompletedFirst Posted
Study publicly available on registry
October 30, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedMay 21, 2007
May 1, 2007
October 29, 2003
May 17, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state.
Secondary Outcomes (7)
HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
HAMD17 Time-to-First Response defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.
HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint.
Hamilton Anxiety Rating Scale measures the presence and severity of anxiety.
Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment.
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Must be at least 18 years of age
- Must be diagnosed with depression
- Must sign informed consent
- Women who can become pregnant must be using birth control
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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 - 5 PM Easter Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
La Rochelle, France
Related Publications (1)
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.
PMID: 25080392DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 29, 2003
First Posted
October 30, 2003
Study Start
July 1, 2003
Study Completion
May 1, 2004
Last Updated
May 21, 2007
Record last verified: 2007-05