A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
NCT ID: NCT00849693
Last Updated: 2012-04-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
463 participants
INTERVENTIONAL
2009-03-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase)
Fluoxetine
fluoxetine
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)
Duloxetine 60 mg
duloxetine
60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)
Duloxetine 30 mg
duloxetine
30 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)
Interventions
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Placebo
Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase)
fluoxetine
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)
duloxetine
60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)
duloxetine
30 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Have a positive urine drug screen for any substances of abuse or excluded medication.
* Are taking any excluded medications that cannot be discontinued by screening.
* Have known hypersensitivity to duloxetine, fluoxetine, or their inactive ingredients; or have frequent or severe allergic reactions to multiple medications.
* Have uncontrolled narrow-angle glaucoma.
* Have acute liver injury or severe cirrhosis.
* Have a serious or unstable medical illness, psychological condition, or clinically significant laboratory or electrocardiogram (ECG) result that, in the opinion of the investigator, would compromise participation in the study or be likely to lead to hospitalization.
* Have abnormal thyroid-stimulating hormone concentration.
* Have initiated or discontinued hormone therapy within the previous 3 months.
* Female patients who are either pregnant, nursing or have recently given birth.
* Need to use thioridazine during the study or within 5 weeks after discontinuation of study drug or need to use pimozide during the study.
7 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Little Rock, Arkansas, United States
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Carson, California, United States
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Escondido, California, United States
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Imperial, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Middletown, Connecticut, United States
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Bradenton, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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North Miami, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
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Oak Brook, Illinois, United States
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Terre Haute, Indiana, United States
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Wichita, Kansas, United States
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Lake Charles, Louisiana, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
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Rockville, Maryland, United States
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Clinton Twp, Michigan, United States
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Lincoln, Nebraska, United States
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Albuquerque, New Mexico, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Salem, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dalllas, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Wharton, Texas, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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West Allis, Wisconsin, United States
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Buenos Aires, , Argentina
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Kelowna, British Columbia, Canada
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Parry Sound, Ontario, Canada
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Toronto, Ontario, Canada
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Aguascalientes, , Mexico
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Guadalajara, , Mexico
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León, , Mexico
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Mexico City, , Mexico
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Mérida, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Tlalnepantla, , Mexico
Countries
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References
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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.
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.
Other Identifiers
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F1J-MC-HMCL
Identifier Type: OTHER
Identifier Source: secondary_id
7109
Identifier Type: -
Identifier Source: org_study_id
NCT00892294
Identifier Type: -
Identifier Source: nct_alias
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