- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00489775
Duloxetine Versus Paroxetine for Major Depression
June 19, 2007 updated by: Eli Lilly and Company
Duloxetine Versus Paroxetine in the Acute Treatment of Major Depression
To determine if duloxetine works just as well as paroxetine in the treatment of major depressive disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
480
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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
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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
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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
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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)
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To compare the efficacy of duloxetine 60 mg QD and paroxetine 20 mg QD as measured by response and remission rates
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
June 19, 2007
First Submitted That Met QC Criteria
June 19, 2007
First Posted (Estimate)
June 21, 2007
Study Record Updates
Last Update Posted (Estimate)
June 21, 2007
Last Update Submitted That Met QC Criteria
June 19, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Mood Disorders
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Cytochrome P-450 CYP2D6 Inhibitors
- Duloxetine Hydrochloride
- Paroxetine
Other Study ID Numbers
- 6937
- F1J-AA-HMCV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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