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A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients

NCT ID: NCT00536471

Last Updated: 2009-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

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Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. Data from the two trials will be reported in both individual and pooled analyses. Pooling the two studies will allow for increased power to detect differences between duloxetine and placebo on secondary and exploratory objectives. Only one data lock is planned for this study, when all patients have completed all study procedures.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

duloxetine 60 milligrams (mg) every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months

Group Type EXPERIMENTAL

Duloxetine hydrochloride

Intervention Type DRUG

B

placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Duloxetine hydrochloride

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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LY248686 Cymbalta

Eligibility Criteria

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Inclusion Criteria

* Male or female outpatients
* Aged 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
* Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at visits 1 and 2
* Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at visits 1 and 2
* Have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

Exclusion Criteria

* Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
* Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia
* Patients who have any current (within the past six months) DSM-IV-TR primary Axis I disorder other than MDD
* Patients with uncontrolled narrow-angle glaucoma
* Patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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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Beverly Hills, California, United States

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Escondido, California, United States

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National City, California, United States

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Hamden, Connecticut, United States

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New Britain, Connecticut, United States

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New London, Connecticut, United States

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Wilmington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Maitland, Florida, United States

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Atlanta, Georgia, United States

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Edwardsville, Illinois, United States

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Hoffman Estates, Illinois, United States

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Naperville, Illinois, United States

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Oak Brook, Illinois, United States

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Lafayette, Indiana, United States

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Terre Haute, Indiana, United States

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Prairie Village, Kansas, United States

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Baltimore, Maryland, United States

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Glen Burnie, Maryland, United States

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Rockville, Maryland, United States

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Belmont, Massachusetts, United States

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Pittsfield, Massachusetts, United States

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Chesterfield, Missouri, United States

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City of Saint Peters, Missouri, United States

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St Louis, Missouri, United States

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Clementon, New Jersey, United States

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Cedarhurst, New York, United States

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New York, New York, United States

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Olean, New York, United States

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Staten Island, New York, United States

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Allentown, Pennsylvania, United States

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Media, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Lake Jackson, Texas, United States

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Arlington, Virginia, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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Brown Deer, Wisconsin, United States

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West Allis, Wisconsin, United States

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Arecibo, , Puerto Rico

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Caguas, , Puerto Rico

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Ponce, , Puerto Rico

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San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.

Reference Type DERIVED
PMID: 25980552 (View on PubMed)

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-US-HMFS

Identifier Type: -

Identifier Source: secondary_id

11669

Identifier Type: -

Identifier Source: org_study_id