NCT00406848

Brief Summary

The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for phase_4 major-depressive-disorder

Timeline
Completed

Started Nov 2006

Typical duration for phase_4 major-depressive-disorder

Geographic Reach
4 countries

33 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

November 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 29, 2010

Completed
Last Updated

September 29, 2010

Status Verified

September 1, 2010

Enrollment Period

2.7 years

First QC Date

November 29, 2006

Results QC Date

July 22, 2010

Last Update Submit

September 13, 2010

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale

    The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).

    baseline (Week 1), Week 13

Secondary Outcomes (27)

  • Change From Baseline on the 30-item Geriatric Depression Scale (GDS)

    baseline (Week 1), Week 13, Week 25

  • Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items

    baseline (Week 1), Week 13, Week 25

  • Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores

    baseline (Week 1), Week 13, Week 25

  • Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores

    baseline (Week 1), Week 13, Week 25

  • Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks

    Week 13, Week 25

  • +22 more secondary outcomes

Study Arms (2)

Duloxetine

EXPERIMENTAL
Drug: duloxetine hydrochloride

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

duloxetine hydrochlorideDRUG

Placebo for 1 week (double-blind placebo lead-in), then duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.

Also known as: LY248686, Cymbalta
Duloxetine
placeboDRUG

Placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Are male or female outpatients at least 65 years of age 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 Mini Mental Score Exam (MMSE) score of at least 20 at Visit 1
  • Have a degree of understanding such that the patient can 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
  • Have any prior history of bipolar disorder, panic disorder, psychosis, schizophrenia, or obsessive-compulsive disorder
  • Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
  • Have moderate to severe dementia
  • Have a serious medical illness, including any cardiovascular (CV), hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

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.

Pasadena, California, 91107, United States

Location

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Sherman Oaks, California, 91403, United States

Location

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Hamden, Connecticut, 06518, United States

Location

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Coral Springs, Florida, 33065, United States

Location

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West Palm Beach, Florida, 33407, United States

Location

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Atlanta, Georgia, 30328, United States

Location

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Hoffman Estates, Illinois, 60194, United States

Location

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Lake Charles, Louisiana, 70601, United States

Location

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Gaithersburg, Maryland, 20877, United States

Location

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Glen Burnie, Maryland, 21061, United States

Location

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Fall River, Massachusetts, 02721, United States

Location

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Nashua, New Hampshire, 03060, United States

Location

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Toms River, New Jersey, 08755, United States

Location

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Olean, New York, 14760, United States

Location

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Staten Island, New York, 10312, United States

Location

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Oklahoma City, Oklahoma, 73109, 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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Bartlett, Tennessee, 38134, United States

Location

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Memphis, Tennessee, 38105, United States

Location

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Wichita Falls, Texas, 76309, United States

Location

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Charleston, West Virginia, 25301, United States

Location

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Brown Deer, Wisconsin, 53223, United States

Location

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Arcachon, 33120, France

Location

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Douai, 59500, France

Location

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Limoges, 87025, France

Location

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Metz, 57020, France

Location

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Nice, 06002, France

Location

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Strasbourg, 67000, France

Location

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Valence, 26000, France

Location

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Mexico City, 14050, Mexico

Location

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Monterrey, 64710, Mexico

Location

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Ponce, 00731-7779, Puerto Rico

Location

Related Publications (3)

  • 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

  • Nelson JC, Oakes TM, Liu P, Ahl J, Bangs ME, Raskin J, Perahia DG, Robinson MJ. Assessment of falls in older patients treated with duloxetine: a secondary analysis of a 24-week randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2013;15(1):PCC.12m01419. doi: 10.4088/PCC.12m01419. Epub 2012 Jan 3.

    PMID: 23724353DERIVED

  • Oakes TM, Katona C, Liu P, Robinson M, Raskin J, Greist JH. Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies. Int Clin Psychopharmacol. 2013 Jan;28(1):1-11. doi: 10.1097/YIC.0b013e32835b09cd.

    PMID: 23138680DERIVED

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 to 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

November 29, 2006

First Posted

December 4, 2006

Study Start

November 1, 2006

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

September 29, 2010

Results First Posted

September 29, 2010

Record last verified: 2010-09

Locations

US(23)PR(1)ME(2)FR(7)