Duloxetine Versus Paroxetine for Major Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-06-30

Brief Summary

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

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Duloxetine

Intervention Type DRUG

Paroxetine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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China

References

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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.

Reference Type DERIVED

PMID: 25080392 (View on PubMed)

Other Identifiers

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F1J-AA-HMCV

Identifier Type: -

Identifier Source: secondary_id

6937