Duloxetine vs. Active Comparator for the Treatment of 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

PHASE4

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-03-31

Brief Summary

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How duloxetine compares to a medication currently available for the treatment of depression in the treatment of patients with major depressive disorder.

The safety of duloxetine and any side effects that might be associated with it.

Detailed Description

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Conditions

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Depression

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 Hydrochloride

Intervention Type DRUG

Venlafaxine Extended Release

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* must be at least 18 years of age
* must be diagnosed with depression
* must sign informed consent

Exclusion Criteria

* women who can become pregnant must be using birth control
* 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

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.

Calgary, Alberta, Canada

Site Status

Countries

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Canada

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-MC-HMCQ

Identifier Type: -

Identifier Source: secondary_id

7999