NCT00666757

Brief Summary

The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started May 2008

Shorter than P25 for phase_4 depression

Geographic Reach
1 country

61 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

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 15, 2010

Completed
Last Updated

June 15, 2010

Status Verified

May 1, 2010

Enrollment Period

9 months

First QC Date

April 23, 2008

Results QC Date

February 16, 2010

Last Update Submit

May 12, 2010

Conditions

Depression

Keywords

Severe Depressive Episode

Outcome Measures

Primary Outcomes (1)

  • Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]

    Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score \[TS\]\</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit \& continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups.

    12 weeks

Secondary Outcomes (20)

  • Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)

    Baseline, 12 weeks

  • Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]

    12 weeks

  • Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]

    Baseline, 12-Weeks

  • Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]

    Baseline, 12-Weeks

  • Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)

    Baseline, 12 Weeks

  • +15 more secondary outcomes

Other Outcomes (4)

  • Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint

    Baseline, 12 Weeks

  • Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint

    Baseline, 12 weeks

  • Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint

    Baseline, 12 Weeks

  • +1 more other outcomes

Study Arms (5)

duloxetine

EXPERIMENTAL

study drug

Drug: duloxetine

citalopram

ACTIVE COMPARATOR
Drug: citalopram

fluoxetine

ACTIVE COMPARATOR
Drug: fluoxetine

paroxetine

ACTIVE COMPARATOR
Drug: paroxetine

sertraline

ACTIVE COMPARATOR
Drug: sertraline

Interventions

duloxetineDRUG

30-120 milligrams (mgs) orally daily for 12 weeks

Also known as: LY248686, Cymbalta
duloxetine
fluoxetineDRUG

20-80 mgs orally daily for 12 weeks

fluoxetine
citalopramDRUG

20-40 mgs orally daily for 12 weeks

citalopram
paroxetineDRUG

20-50 mgs orally daily for 12 weeks

paroxetine
sertralineDRUG

50-200 mgs orally daily for 12 weeks

sertraline

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • Have major depression and are currently in a severe depressive episode
  • Have a degree of understanding such that patient can communicate with the investigator and study staff
  • All females must test negative for pregnancy
  • Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug

You may not qualify if:

  • Have not responded to duloxetine for depression in the past
  • Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
  • Are at significant risk for suicide
  • Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
  • Have a serious, unstable medical condition
  • Have a current or recent history of substance abuse or dependence
  • Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
  • Have started psychotherapy within 6 weeks prior to study entry
  • Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (61)

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Carson, California, 90746, United States

Location

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Irvine, California, 92618, United States

Location

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San Diego, California, 92108, United States

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Sherman Oaks, California, 91403, United States

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Torrance, California, 90502, United States

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Pueblo, Colorado, 81008, United States

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Clearwater, Florida, 33765, United States

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Coral Springs, Florida, 33065, United States

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Deerfield Beach, Florida, 33064, United States

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Fort Myers, Florida, 33912, United States

Location

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Gainesville, Florida, 32607, United States

Location

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Hialeah, Florida, 33016, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33173, United States

Location

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30338, United States

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Joliet, Illinois, 60435, United States

Location

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Oak Brook, Illinois, 60523, United States

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Park Ridge, Illinois, 60068, United States

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Greenwood, Indiana, 46143, United States

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Terre Haute, Indiana, 47802, United States

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Prairie Village, Kansas, 66206, United States

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Wichita, Kansas, 67203, United States

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Gaithersburg, Maryland, 20877, United States

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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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Fall River, Massachusetts, 02721, 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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Princeton, New Jersey, 08540, United States

Location

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Brooklyn, New York, 11223, United States

Location

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Fresh Meadows, New York, 11366, United States

Location

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Mount Kisco, New York, 10549, United States

Location

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Rochester, New York, 14618, United States

Location

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Staten Island, New York, 10312, United States

Location

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Concord, North Carolina, 28025, United States

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Durham, North Carolina, 27707, United States

Location

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Beachwood, Ohio, 44122, United States

Location

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Dayton, Ohio, 45432, United States

Location

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Kettering, Ohio, 45429, United States

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Oklahoma City, Oklahoma, 73119, United States

Location

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Eugene, Oregon, 97404, United States

Location

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Havertown, Pennsylvania, 19083, United States

Location

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Media, Pennsylvania, 19063, United States

Location

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Newtown, Pennsylvania, 18940, United States

Location

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Philadelphia, Pennsylvania, 19139, United States

Location

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Lincoln, Rhode Island, 02865, United States

Location

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Columbia, South Carolina, 29201, United States

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Sioux Falls, South Dakota, 57105, United States

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Austin, Texas, 78756, United States

Location

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Dallas, Texas, 75231, United States

Location

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Friendswood, Texas, 77546, United States

Location

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Houston, Texas, 77074, United States

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Lake Jackson, Texas, 77566, United States

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San Antonio, Texas, 78229, United States

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Wichita Falls, Texas, 76309, United States

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Woodstock, Vermont, 05091, United States

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Charlottesville, Virginia, 22903, United States

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Herndon, Virginia, 20170, United States

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Bellevue, Washington, 98004, United States

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Brown Deer, Wisconsin, 53223, United States

Location

Related Publications (2)

  • 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

  • Martinez JM, Katon W, Greist JH, Kroenke K, Thase ME, Meyers AL, Edwards SE, Marangell LB, Shoemaker S, Swindle R. A pragmatic 12-week, randomized trial of duloxetine versus generic selective serotonin-reuptake inhibitors in the treatment of adult outpatients in a moderate-to-severe depressive episode. Int Clin Psychopharmacol. 2012 Jan;27(1):17-26. doi: 10.1097/YIC.0b013e32834ce11b.

    PMID: 22027844DERIVED

Related Links

MeSH Terms

Conditions

Depression

Interventions

Duloxetine HydrochlorideFluoxetineCitalopramParoxetineSertraline

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperidines1-NaphthylamineNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic 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 9AM - 5PM 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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

May 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

June 15, 2010

Results First Posted

June 15, 2010

Record last verified: 2010-05

Locations

US(61)