Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

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

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2003-07-31

Brief Summary

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The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.

Detailed Description

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Conditions

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Depressive Disorder

Keywords

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Major Depressive Disorder Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Duloxetine Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed the informed consent
* Meet criteria for major depressive disorder without psychotic features.
* Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.
* Have had at least one other major depressive episode prior to the one being experienced at study entry.
* You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol.

Exclusion Criteria

* You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
* Any women who are pregnant or breast feeding.
* If you have any serious medical illnesses other than major depressive disorder.
* If you have previously participated in a clinical trial for duloxetine.
* Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Hudson JI, Perahia DG, Gilaberte I, Wang F, Watkin JG, Detke MJ. Duloxetine in the treatment of major depressive disorder: an open-label study. BMC Psychiatry. 2007 Aug 28;7:43. doi: 10.1186/1471-244X-7-43.

Reference Type DERIVED

PMID: 17725843 (View on PubMed)

Other Identifiers

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F1J-MC-HMBC

Identifier Type: -

Identifier Source: secondary_id

4445