Duloxetine Versus Paroxetine for Major Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Duloxetine
Paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- You are male or female at least 18 years of age with nonpsychotic major depression. Females of child-bearing potential must test negative on a pregnancy test at visit 1.
Exclusion Criteria:
- You have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality.
- You have a history of hepatic dysfunction, current jaundice, or positive hepatitis B surface Antigen or positive hepatitis C surface Antibody regardless of ALT.
- You have an ALT greater than or equal to 2 times the upper limit of normal.
- You have abnormal thyroid-stimulating hormone concentrations.
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
To assess hypothesis that efficacy of duloxetine 60mg QD is non-inferior to paroxetine 20mg QD in treating major depressive disorder as defined by DSM-IV. Primary efficacy evaluated by mean change of HAMD17 total scores from baseline to endpoint.
Secondary Outcome Measures
To compare the efficacy of duloxetine 60 mg QD and paroxetine 20 mg QD on anxiety symptoms associated with depression as measured by mean changes in Hamilton Anxiety Rating Scale (HAMA) total scores
To compare efficacy of treatment with duloxetine 60 mg QD and paroxetine 20 mg QD on symptoms of depression measured by mean endpoint scale on the Clinical Global Impression of Severity Scale (CGI-S) scale and the endpoint score
To compare efficacy of treatment with duloxetine 60 mg QD and paroxetine 20 mg QD on symptoms of depression measured by the endpoint score on the Patient Global Impression of Improvement (PGI-I) scale
To compare the efficacy of treatment with duloxetine 60 mg QD and paroxetine 20 mg QD on somatic complaints of pain as measured by the Somatic Symptom Inventory Scale (SSI) and Visual Analog Scales for pain (VAS)
To compare the efficacy of duloxetine 60 mg QD and paroxetine 20 mg QD as measured by response and remission rates
To compare the safety of duloxetine 60 mg QD and paroxetine 20 mg QD using information on treatment-emergent adverse events and other safety measures - e.g. electrocardiograms (ECGs) and laboratory tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00489775
Brief Title
Duloxetine Versus Paroxetine for Major Depression
Official Title
Duloxetine Versus Paroxetine in the Acute Treatment of Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if duloxetine works just as well as paroxetine in the treatment of major depressive disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Primary Outcome Measure Information:
Title
To assess hypothesis that efficacy of duloxetine 60mg QD is non-inferior to paroxetine 20mg QD in treating major depressive disorder as defined by DSM-IV. Primary efficacy evaluated by mean change of HAMD17 total scores from baseline to endpoint.
Secondary Outcome Measure Information:
Title
To compare the efficacy of duloxetine 60 mg QD and paroxetine 20 mg QD on anxiety symptoms associated with depression as measured by mean changes in Hamilton Anxiety Rating Scale (HAMA) total scores
Title
To compare efficacy of treatment with duloxetine 60 mg QD and paroxetine 20 mg QD on symptoms of depression measured by mean endpoint scale on the Clinical Global Impression of Severity Scale (CGI-S) scale and the endpoint score
Title
To compare efficacy of treatment with duloxetine 60 mg QD and paroxetine 20 mg QD on symptoms of depression measured by the endpoint score on the Patient Global Impression of Improvement (PGI-I) scale
Title
To compare the efficacy of treatment with duloxetine 60 mg QD and paroxetine 20 mg QD on somatic complaints of pain as measured by the Somatic Symptom Inventory Scale (SSI) and Visual Analog Scales for pain (VAS)
Title
To compare the efficacy of duloxetine 60 mg QD and paroxetine 20 mg QD as measured by response and remission rates
Title
To compare the safety of duloxetine 60 mg QD and paroxetine 20 mg QD using information on treatment-emergent adverse events and other safety measures - e.g. electrocardiograms (ECGs) and laboratory tests
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
You are male or female at least 18 years of age with nonpsychotic major depression. Females of child-bearing potential must test negative on a pregnancy test at visit 1.
Exclusion Criteria:
You have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality.
You have a history of hepatic dysfunction, current jaundice, or positive hepatitis B surface Antigen or positive hepatitis C surface Antibody regardless of ALT.
You have an ALT greater than or equal to 2 times the upper limit of normal.
You have abnormal thyroid-stimulating hormone concentrations.
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
Beijing
Country
China
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 Versus Paroxetine for Major Depression
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