Duloxetine Versus Paroxetine for Major Depression - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00489775

Purpose

To determine if duloxetine works just as well as paroxetine in the treatment of major depressive disorder.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Duloxetine Drug: Paroxetine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duloxetine Versus Paroxetine in the Acute Treatment of Major Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Duloxetine Duloxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

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

Estimated Enrollment:	480
Study Start Date:	January 2004
Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489775

Locations

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.
Beijing, China

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	6937, F1J-AA-HMCV
Study First Received:	June 19, 2007
Last Updated:	June 19, 2007
ClinicalTrials.gov Identifier:	NCT00489775 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Paroxetine
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Behavioral Symptoms
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Paroxetine

Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 01, 2009