NCT01070329

Brief Summary

The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
527

participants targeted

Target at P75+ for phase_4 major-depressive-disorder

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_4 major-depressive-disorder

Geographic Reach
2 countries

34 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

February 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
12 months until next milestone

Results Posted

Study results publicly available

February 13, 2012

Completed
Last Updated

February 13, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

February 16, 2010

Results QC Date

January 10, 2012

Last Update Submit

January 10, 2012

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period

    A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.

    Day 1 through 8 weeks

  • Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8

    The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment\*visit interaction, and baseline\*visit interaction.

    Baseline, 8 weeks

Secondary Outcomes (8)

  • Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8

    Baseline, 8 weeks

  • Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8

    Baseline, up to 8 weeks

  • Percentage of Participants Achieving Remission up to Week 8

    Up to 8 weeks

  • Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4

    Baseline, 4 weeks

  • Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2

    Baseline, 2 weeks

  • +3 more secondary outcomes

Other Outcomes (4)

  • Change From Baseline in Pulse Rate up to Week 8

    Baseline, up to week 8

  • Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8

    Baseline, up to week 8

  • Change From Baseline in Weight up to Week 8

    Baseline, up to week 8

  • +1 more other outcomes

Study Arms (2)

Duloxetine

EXPERIMENTAL
Drug: Duloxetine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DuloxetineDRUG

Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.

Also known as: LY248686, Cymbalta
Duloxetine
PlaceboDRUG

Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Meets criteria for Major Depressive Disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (MINI)
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20 during the Screening Phase
  • At least 1 previous episode of depression
  • Painful physical symptoms with a score greater than or equal to 3 on the Brief Pain Inventory-Short Form (BPI-SF) average pain question
  • A Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 during the Screening Phase
  • Written informed consent

You may not qualify if:

  • Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
  • Have previously completed or withdrawn from this study or any other study investigating duloxetine (unless no study drug was received)
  • Women of child-bearing potential who are not using a medically accepted means of contraception
  • Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
  • Have a history of alcohol abuse and/or substance abuse or dependence within 1 year prior to being screened for the study
  • Have any prior history of bipolar disorder, psychosis, or schizophrenia
  • Have an Axis II disorder that would interfere with study compliance
  • Lack of response of any episode of major depression (lifetime of subject) to two or more adequate courses of antidepressant therapy, at a clinically appropriate dose for at least 4 weeks or, alternatively, in the judgment of the investigator, the subject meets criteria for treatment resistant depression
  • Have previously received treatment of MDD or Generalized Anxiety Disorder (GAD) with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine
  • Diagnosis of acute liver injury or severe cirrhosis
  • Uncontrolled narrow-angle glaucoma
  • Positive urine drug screen for any substance of abuse
  • Have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention, hospitalization, or use of an excluded medication during the study
  • History of a serious suicide attempt or subject judged clinically to be at serious suicidal risk
  • Requires continuous use of analgesics for 6 or more months because of chronic pain
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

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.

Sherman Oaks, California, 91403, United States

Location

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.

Cromwell, Connecticut, 06416, United States

Location

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Fort Lauderdale, Florida, 33319, United States

Location

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Orlando, Florida, 32806, United States

Location

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Atlanta, Georgia, 30308, United States

Location

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Hoffman Estates, Illinois, 60194, United States

Location

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Springfield, Illinois, 62711, United States

Location

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Evansville, Indiana, 47714, United States

Location

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Florence, Kentucky, 41042, United States

Location

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Lake Charles, Louisiana, 70601, United States

Location

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Belmont, Massachusetts, 02478, United States

Location

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Boston, Massachusetts, 02135, United States

Location

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Troy, Michigan, 48083, United States

Location

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Toms River, New Jersey, 08755, United States

Location

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Willingboro, New Jersey, 08046, United States

Location

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Brooklyn, New York, 11235, United States

Location

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Rochester, New York, 14618, United States

Location

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Staten Island, New York, 10305, United States

Location

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Beachwood, Ohio, 44122, United States

Location

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Toledo, Ohio, 43623, United States

Location

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Oklahoma City, Oklahoma, 73109, United States

Location

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Portland, Oregon, 97210, United States

Location

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Salem, Oregon, 97301, 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, 19107, United States

Location

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Lincoln, Rhode Island, 02865, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Wichita Falls, Texas, 76309, United States

Location

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Richmond, Virginia, 23230, United States

Location

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Bellevue, Washington, 98007, United States

Location

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Middleton, Wisconsin, 53562, United States

Location

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Caguas, 00725, Puerto Rico

Location

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San Juan, 00926, Puerto Rico

Location

Related Publications (2)

  • Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400. doi: 10.1002/sim.1526.

    PMID: 12872297BACKGROUND

  • Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Hann D, Marangell LB. Duloxetine versus placebo in the treatment of major depressive disorder and associated painful physical symptoms: a replication study. Curr Med Res Opin. 2011 Oct;27(10):1859-67. doi: 10.1185/03007995.2011.609540. Epub 2011 Aug 12.

    PMID: 21838410DERIVED

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 18, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 13, 2012

Results First Posted

February 13, 2012

Record last verified: 2012-01

Locations

US(32)PR(2)