A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
NCT ID: NCT00849901
Last Updated: 2017-09-11
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
337 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-03-31
Study Completion Date
2011-10-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Major Depressive Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Capsules identical in appearance, color, taste and smell to study drug, orally (PO), once daily (QD). Dose: placebo, 6 capsules, QD for 10 weeks
Fluoxetine
Group Type
ACTIVE_COMPARATOR
fluoxetine
Intervention Type
DRUG
10-40 milligram (mg), PO, QD, for up to 38 weeks
Duloxetine
Group Type
EXPERIMENTAL
duloxetine
Intervention Type
DRUG
30-120 mg, PO, QD, for up to 38 weeks
Interventions
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duloxetine
30-120 mg, PO, QD, for up to 38 weeks
Intervention Type
DRUG
Placebo
Capsules identical in appearance, color, taste and smell to study drug, orally (PO), once daily (QD). Dose: placebo, 6 capsules, QD for 10 weeks
Intervention Type
DRUG
fluoxetine
10-40 milligram (mg), PO, QD, for up to 38 weeks
Intervention Type
DRUG
Other Intervention Names
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LY248686
Cymbalta
LY110140
Prozac
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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 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.
* 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.
* 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.
Minimum Eligible Age
7 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Costa Mesa, California, United States
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Irvine, California, United States
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Palo Alto, California, United States
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Altamonte Springs, Florida, United States
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Fort Lauderdale, Florida, United States
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Marietta, Georgia, United States
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Smyrna, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Libertyville, Illinois, United States
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Rochester Hills, Michigan, United States
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Saint Charles, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Willingboro, New Jersey, United States
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Rochester, New York, United States
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Wilmington, North Carolina, United States
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Beachwood, Ohio, United States
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Middleburg Heights, Ohio, United States
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Bartlett, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Clinton, Utah, United States
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Orem, Utah, United States
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Élancourt, , France
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Paris, , France
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Rouffach, , France
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Cologne, , Germany
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Mannheim, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Kazan', , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Stavropol, , Russia
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Tomsk, , Russia
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Košice, , Slovakia
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Martin, , Slovakia
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Centurion, , South Africa
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Johannesburg, , South Africa
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Pretoria, , South Africa
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Vereeniging, , South Africa
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West Cape, , South Africa
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Luhansk, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
Site Status
Countries
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United States
France
Germany
Russia
Slovakia
South Africa
Ukraine
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.
Reference Type
DERIVED
Atkinson SD, Prakash A, Zhang Q, Pangallo BA, Bangs ME, Emslie GJ, March JS. A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):180-9. doi: 10.1089/cap.2013.0146. Epub 2014 May 9.
Reference Type
DERIVED
Bliznak L, Berg R, Hage A, Dittmann RW. High rate of non-eligibility: methodological factors impacting on recruitment for a multicentre, double-blind study of paediatric patients with major depressive disorder. Pharmacopsychiatry. 2013 Jan;46(1):23-8. doi: 10.1055/s-0032-1314806. Epub 2012 Jun 14.
Reference Type
DERIVED
Other Identifiers
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F1J-MC-HMCK
Identifier Type: OTHER
Identifier Source: secondary_id
6223
Identifier Type: -
Identifier Source: org_study_id
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