NCT00849693

Brief Summary

The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
463

participants targeted

Target at P50-P75 for phase_3 major-depressive-disorder

Timeline
Completed

Started Mar 2009

Typical duration for phase_3 major-depressive-disorder

Geographic Reach
4 countries

56 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 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 19, 2012

Completed
Last Updated

April 19, 2012

Status Verified

March 1, 2012

Enrollment Period

1.9 years

First QC Date

February 23, 2009

Results QC Date

February 22, 2012

Last Update Submit

March 26, 2012

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint

    CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit and baseline\*visit.

    Baseline, Week 10

Secondary Outcomes (12)

  • Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint

    Week 10, Week 36

  • Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint

    Baseline, Week 10

  • Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint

    Baseline, Week 10

  • Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint

    Week 10, Week 36

  • Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint

    Baseline, Week 10

  • +7 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Fluoxetine

ACTIVE COMPARATOR
Drug: fluoxetine

Duloxetine 60 mg

EXPERIMENTAL
Drug: duloxetine

Duloxetine 30 mg

EXPERIMENTAL
Drug: duloxetine

Interventions

PlaceboDRUG

Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase)

Placebo
fluoxetineDRUG

20 milligram (mg) orally, once daily for 10 weeks (acute treatment phase) and 20-40 mg orally, once daily for additional 6 months (extension phase)

Also known as: LY110140, Prozac
Fluoxetine
duloxetineDRUG

60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)

Also known as: LY248686, Cymbalta
Duloxetine 60 mg

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Outpatient, diagnosed with major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and supported by the Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID).
  • Diagnosis of moderate or greater severity of MDD as determined by Children's Depression Rating Scale - Revised (CDRS-R) with a total score greater than or equal to 40 at screen, and randomization and a Clinical Global Impression of Severity (CGI-Severity) rating of greater than or equal to 4 at screen, and randomization.
  • Female patients must test negative for pregnancy during screening.
  • Judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol.
  • Has a degree of understanding such that they can communicate intelligently with the investigator and study coordinator.
  • Capable of swallowing study drug whole. It is anticipated the patients will need to swallow up to 6 capsules per day.
  • Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol.

You may not qualify if:

  • Children of site personnel directly affiliated with this study and/or their immediate families.
  • Children of Lilly employees or employees of the designated clinical research organization (CRO) assisting with the conduct of the study.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or pervasive development disorder, as judged by the investigator.
  • Have a history of DSM-IV-TR-defined substance abuse or dependence within the past year, excluding caffeine and nicotine.
  • Have a current primary DSM-IV-TR Axis I disorder other than MDD or a current secondary DSM-IV-TR Axis I disorder that requires any pharmacologic treatment
  • Have 1 or more first-degree relatives with diagnosed bipolar I disorder.
  • Have a significant suicide attempt within 1 year of screening or are currently at risk of suicide in the opinion of the investigator.
  • Have a weight less than 20 kilogram (kg) at screening.
  • Have a lack of response to 2 or more adequate treatment trials of antidepressants at a clinically appropriate dose for a minimum of 4 weeks for the same MDD episode.
  • Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks prior to screening.
  • Have a history of seizure disorder (other than febrile seizures).
  • Have a history of electroconvulsive therapy within 1 year of screening.
  • Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days or fluoxetine within 30 days of randomization; or the potential need to use an MAOI during the study or within 5 weeks of discontinuation of study drug.
  • Have previously enrolled, completed, or withdrawn from this study or any other study investigating duloxetine or fluoxetine.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (56)

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Birmingham, Alabama, 35216, United States

Location

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Dothan, Alabama, 36303, United States

Location

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Little Rock, Arkansas, 72223, United States

Location

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Carson, California, 90746, United States

Location

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Escondido, California, 92025, United States

Location

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Imperial, California, 92251, United States

Location

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Riverside, California, 92506, United States

Location

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San Diego, California, 92123, United States

Location

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Aurora, Colorado, 80045, United States

Location

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Middletown, Connecticut, 06457, United States

Location

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Bradenton, Florida, 34208, United States

Location

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Gainesville, Florida, 32607, United States

Location

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Hialeah, Florida, 33013, United States

Location

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Jacksonville, Florida, 32216, United States

Location

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North Miami, Florida, 33161, United States

Location

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Tampa, Florida, 33613, United States

Location

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West Palm Beach, Florida, 33407, United States

Location

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Winter Park, Florida, 32789, United States

Location

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Oak Brook, Illinois, 60523, United States

Location

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Terre Haute, Indiana, 47802, United States

Location

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Wichita, Kansas, 67114, United States

Location

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Lake Charles, Louisiana, 70601, United States

Location

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Baltimore, Maryland, 21208, 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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Clinton Twp, Michigan, 48038, United States

Location

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Lincoln, Nebraska, 68510, United States

Location

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Albuquerque, New Mexico, 87109, United States

Location

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Cincinnati, Ohio, 45219, United States

Location

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Cleveland, Ohio, 44106, United States

Location

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Oklahoma City, Oklahoma, 73139, United States

Location

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Salem, Oregon, 97301, United States

Location

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Philadelphia, Pennsylvania, 19139, United States

Location

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Charleston, South Carolina, 29407, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Austin, Texas, 78731, United States

Location

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Dalllas, Texas, 75235, United States

Location

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Houston, Texas, 77008, United States

Location

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Lake Jackson, Texas, 77566, United States

Location

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Wharton, Texas, 77488, 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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Seattle, Washington, 98104, United States

Location

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West Allis, Wisconsin, 53227, United States

Location

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Buenos Aires, C1058AAJ, Argentina

Location

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Kelowna, British Columbia, V1Y 1Z9, Canada

Location

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Parry Sound, Ontario, P2A 3A4, Canada

Location

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Toronto, Ontario, M6J 3S3, Canada

Location

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Aguascalientes, 20217, Mexico

Location

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Guadalajara, 44630, Mexico

Location

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León, 37000, Mexico

Location

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Mexico City, 7810, Mexico

Location

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Mérida, 97000, Mexico

Location

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Monterrey, 64710, Mexico

Location

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Morelia, 58260, Mexico

Location

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Tlalnepantla, 53160, Mexico

Location

Related Publications (2)

  • Emslie GJ, Wells TG, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):293-305. doi: 10.1089/cap.2014.0076.

    PMID: 25978741DERIVED

  • Emslie GJ, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):170-9. doi: 10.1089/cap.2013.0096. Epub 2014 May 9.

    PMID: 24815533DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

FluoxetineDuloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsThiophenesSulfur CompoundsHeterocyclic 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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2011

Study Completion

September 1, 2011

Last Updated

April 19, 2012

Results First Posted

April 19, 2012

Record last verified: 2012-03

Locations

ME(8)CA(3)US(44)AR(1)