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

NCT ID: NCT00105989

Last Updated: 2009-07-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

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Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

B

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Duloxetine

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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LY248686 Cymbalta

Eligibility Criteria

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Inclusion Criteria

* Patient must be at least 18 years old.
* Patient must be diagnosed with depression and have had previous episodes of depression.
* Patient must sign informed consent.

Exclusion Criteria

* Female and pregnant or breastfeeding.
* History of bipolar disorder, schizophrenia, or other psychotic disorders.
* Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.
* Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.
* Have taken an antidepressant called fluoxetine within 30 days of the start of the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Newport Beach, California, United States

Site Status

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Sherman Oaks, California, United States

Site Status

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Baltimore, Maryland, United States

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Gaithersburg, Maryland, United States

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Brooklyn, New York, United States

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Angoulême, , France

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Douai, , France

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Fains, , France

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La Rochelle, , France

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Lille, , France

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Nîmes, , France

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Roubaix, , France

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Strasbourg, , France

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Berlin, , Germany

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Ellwangen, , Germany

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Hamburg, , Germany

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Hildesheim, , Germany

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Leipzig, , Germany

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München, , Germany

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Würzburg, , Germany

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Catania, , Italy

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Ferrara, , Italy

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Florence, , Italy

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Parma, , Italy

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Roma, , Italy

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Torino, , Italy

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Moscow, , Russia

Site Status

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Saint Petersburg, , Russia

Site Status

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Village Nikolskoe, , Russia

Site Status

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Halmstad, , Sweden

Site Status

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Lund, , Sweden

Site Status

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Malmo, , Sweden

Site Status

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Stockholm, , Sweden

Site Status

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Sundsvall, , Sweden

Site Status

Countries

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United States France Germany Italy Russia Sweden

References

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Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16. doi: 10.4088/jcp.08m04756.

Reference Type DERIVED
PMID: 19552867 (View on PubMed)

Other Identifiers

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F1J-MC-HMDI

Identifier Type: -

Identifier Source: secondary_id

8606

Identifier Type: -

Identifier Source: org_study_id

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