Clinical trial NCT00849901: A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
Official title: A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-02-24
Enrollment: 337
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
timeFrame: Baseline, Week 10
Secondary outcomes:
measure: Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint
timeFrame: Week 10, Week 36
measure: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint
timeFrame: Baseline, Week 10
measure: Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint
timeFrame: Week 10, Week 36
measure: Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint
timeFrame: Baseline, Week 10
measure: Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint
timeFrame: Week 10, Week 36
measure: Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10
timeFrame: Baseline through Week 10
measure: Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36
timeFrame: Week 10 through Week 36
measure: Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10
timeFrame: Baseline through Week 10
measure: Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36
timeFrame: Week 10 through Week 36
measure: Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10
timeFrame: Baseline through Week 10
measure: Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36
timeFrame: Week 10 through Week 36
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: 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.
state: California
city: Irvine
country: United States
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state: California
city: Palo Alto
country: United States
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state: California
city: Altamonte Springs
country: United States
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state: Florida
city: Fort Lauderdale
country: United States
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state: Florida
city: Marietta
country: United States
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state: Georgia
city: Smyrna
country: United States
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state: Georgia
city: Coeur d'Alene
country: United States
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state: Idaho
city: Libertyville
country: United States
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state: Illinois
city: Rochester Hills
country: United States
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state: Michigan
city: Saint Charles
country: United States
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state: Missouri
city: Omaha
country: United States
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state: Nebraska
city: Las Vegas
country: United States
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state: Nevada
city: Willingboro
country: United States
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state: New Jersey
city: Rochester
country: United States
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state: New York
city: Staten Island
country: United States
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state: New York
city: Wilmington
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state: North Carolina
city: Beachwood
country: United States
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state: Ohio
city: Middleburg Heights
country: United States
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state: Ohio
city: Bartlett
country: United States
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state: Tennessee
city: Houston
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Clinton
country: United States
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state: Utah
city: Orem
country: United States
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state: Utah
city: Elancourt
country: France
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city: Paris
country: France
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city: Rouffach
country: France
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city: Koeln
country: Germany
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city: Mannheim
country: Germany
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city: Tubingen
country: Germany
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city: Ulm
country: Germany
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city: Kazan
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Nizhniy Novgorod
country: Russian Federation
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city: Novosibirsk
country: Russian Federation
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city: Rostov-On-Don
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
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city: Saratov
country: Russian Federation
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city: Smolensk
country: Russian Federation
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city: Stavropol
country: Russian Federation
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city: Tomsk
country: Russian Federation
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city: Kosice
country: Slovakia
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city: Martin
country: Slovakia
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city: Bloemfontein
country: South Africa
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city: Cape Town
country: South Africa
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city: Centurion
country: South Africa
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city: Johannesburg
country: South Africa
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city: Pretoria
country: South Africa
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city: Vereeniging
country: South Africa
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city: West Cape
country: South Africa
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city: Donetsk
country: Ukraine
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city: Kharkiv
country: Ukraine
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city: Kyiv
country: Ukraine
facility: 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.
city: Lugansk
country: Ukraine
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city: Odesa
country: Ukraine
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city: Poltava
country: Ukraine
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city: Ternopil
country: Ukraine
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city: Uzhorod
country: Ukraine
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city: Vinnytsya
country: Ukraine
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Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.