A Study in the Treatment of Children and Adolescents With Major Depressive Disorder

Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateApril 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: baseline, 10 weeks, 36 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00849901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: February 20, 2009)
  • Clinical Global Impressions of Severity (CGI-Severity) Scale [ Time Frame: baseline, 10 weeks, 36 weeks ] [ Designated as safety issue: No ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 10 weeks, 36 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with potentially clinically significant hepatic laboratory results at anytime by treatment group [ Time Frame: 4,10,14,20,24,36 weeks or last observation ] [ Designated as safety issue: Yes ]
  • Number of patients with potentially clinically significant changes in systolic blood pressure, diastolic blood pressure, pulse, and weight at endpoint by treatment group [ Time Frame: 10 weeks, 36 weeks, or last observation ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study in the Treatment of Children and Adolescents With Major Depressive Disorder
Official Title  ICMJEA Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder
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)

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEMajor Depressive Disorder
Intervention  ICMJE
  • Drug: duloxetine
    30-120mg, PO, QD (once daily), for up to 38 weeks
    Other Names:
    • LY248686
    • Cymbalta
  • Drug: Placebo
    Capsules identical in appearance, color, taste and smell to study drug, PO, QD for Dose: placebo, 6 capsules, QD for 10 weeks
  • Drug: fluoxetine
    10-40mg, PO, QD, for up to 38 weeks
    Other Names:
    • LY110140
    • Prozac
Study Arms / Comparison Groups
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo
  • Fluoxetine: Active Comparator
    Intervention: Drug: fluoxetine
  • Duloxetine: Experimental
    Intervention: Drug: duloxetine

Recruitment Information

Estimated Enrollment  ICMJE336
Estimated Completion DateApril 2012
Estimated Primary Completion DateApril 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatient, diagnosed with MDD as defined by the DSM-IV-TR and supported by the MINI-KID.
  • Diagnosis of moderate or greater severity of MDD as determined by CDRS-R with a total score greater than or equal to 40 at screen, and randomization and a 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 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 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 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 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.
Ages7 Years to 17 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
Location Countries  ICMJEUnited States,   Estonia,   Finland,   France,   Germany,   Puerto Rico,   Russian Federation,   Slovakia,   South Africa,   Ukraine

Administrative Information

Responsible PartyChief Medical Officer, Eli Lilly
Study ID Numbers  ICMJE6223, F1J-MC-HMCK
Study Sponsor  ICMJEEli Lilly and Company
Collaborators  ICMJE 
Investigators  ICMJE
Study Director: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
Information Provided ByEli Lilly and Company