NCT00536471

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
776

participants targeted

Target at P75+ for phase_4 major-depressive-disorder

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4 major-depressive-disorder

Geographic Reach
2 countries

47 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 17, 2009

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

8 months

First QC Date

September 25, 2007

Results QC Date

May 28, 2009

Last Update Submit

November 17, 2009

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)

    Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).

    baseline, 8 weeks

Secondary Outcomes (60)

  • Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale)

    Baseline, 8 weeks, 12 weeks, 9 months

  • Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score

    Baseline, 12 weeks, 9 months

  • Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood

    Baseline, 12 weeks, 9 months

  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt

    Baseline, 12 weeks, 9 months

  • Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide

    Baseline, 12 weeks, 9 Months

  • +55 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

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

Drug: Duloxetine hydrochloride

B

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Duloxetine hydrochlorideDRUG
Also known as: LY248686, Cymbalta
A
PlaceboDRUG
B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

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.

Beverly Hills, California, 90210, United States

Location

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Escondido, California, 92025, United States

Location

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National City, California, 91950, United States

Location

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Hamden, Connecticut, 06518, United States

Location

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New Britain, Connecticut, 06050, United States

Location

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New London, Connecticut, 06320, United States

Location

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Wilmington, Delaware, 19808, United States

Location

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Washington D.C., District of Columbia, 20037, United States

Location

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Bradenton, Florida, 34208, United States

Location

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Fort Myers, Florida, 33912, United States

Location

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Gainesville, Florida, 32606, United States

Location

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Maitland, Florida, 32751, United States

Location

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Atlanta, Georgia, 30328, United States

Location

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Edwardsville, Illinois, 62025, United States

Location

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Hoffman Estates, Illinois, 60169, United States

Location

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Naperville, Illinois, 60540, United States

Location

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Oak Brook, Illinois, 60523, United States

Location

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Lafayette, Indiana, 47905, United States

Location

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Terre Haute, Indiana, 47802, United States

Location

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Prairie Village, Kansas, 66206, United States

Location

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Baltimore, Maryland, 21285, United States

Location

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Glen Burnie, Maryland, 21061, United States

Location

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Rockville, Maryland, 20852, United States

Location

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Belmont, Massachusetts, 02478, United States

Location

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Pittsfield, Massachusetts, 01201, United States

Location

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Chesterfield, Missouri, 63017, United States

Location

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City of Saint Peters, Missouri, 63376, United States

Location

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St Louis, Missouri, 63141, United States

Location

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Clementon, New Jersey, 08021, United States

Location

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Cedarhurst, New York, 11516, United States

Location

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New York, New York, 10021, United States

Location

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Olean, New York, 14760, United States

Location

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Staten Island, New York, 10305, United States

Location

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Allentown, Pennsylvania, 18104, United States

Location

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Media, Pennsylvania, 19063, United States

Location

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Philadelphia, Pennsylvania, 19104, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Lake Jackson, Texas, 77566, United States

Location

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Arlington, Virginia, 22201, United States

Location

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Charlottesville, Virginia, 22903, United States

Location

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Richmond, Virginia, 23230, United States

Location

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Brown Deer, Wisconsin, 53223, United States

Location

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West Allis, Wisconsin, 53227, United States

Location

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Arecibo, 00612, Puerto Rico

Location

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Caguas, 00725, Puerto Rico

Location

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Ponce, 00731, Puerto Rico

Location

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San Juan, 00907, Puerto Rico

Location

Related Publications (2)

  • 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.

    PMID: 25980552DERIVED

  • 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.

    PMID: 25080392DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 27, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2008

Study Completion

December 1, 2008

Last Updated

November 20, 2009

Results First Posted

July 17, 2009

Record last verified: 2009-11

Locations

US(43)PR(4)