A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder

Eli Lilly and Company1 site in 1 country337 target enrollmentMarch 2009

ConditionsMajor Depressive Disorder

InterventionsPlacebo fluoxetine duloxetine

Drugsduloxetine Placebo fluoxetine

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Enrollment: 337
Locations: 1
Primary Endpoint: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

October 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

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.

Arms & Interventions

Placebo

Intervention: Placebo

Fluoxetine

Intervention: fluoxetine

Duloxetine

Intervention: duloxetine

Outcomes

Primary Outcomes

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

Time Frame: Baseline, Week 10

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.

Secondary Outcomes

Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint(Week 10, Week 36)
Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10(Baseline through Week 10)
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36(Week 10 through Week 36)
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 Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint(Week 10, Week 36)
Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint(Week 10, Week 36)
Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10(Baseline through Week 10)
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(Week 10 through Week 36)
Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint(Baseline, Week 10)
Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36(Week 10 through Week 36)
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(Baseline through Week 10)