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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

fluoxetine

duloxetine

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

Fluoxetine

Duloxetine 60 mg

Duloxetine 30 mg

Arm Description

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint

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. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.

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

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

CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.

Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint

Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint

CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.

Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint

Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10

Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0).

Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36

Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10

Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.

Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36

Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.

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

PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.

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

PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.

Full Information

NCT ID

NCT00849693

First Posted

February 23, 2009

Last Updated

March 26, 2012

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00849693

Brief Title

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

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

463 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Fluoxetine

Arm Type

Active Comparator

Arm Title

Duloxetine 60 mg

Arm Type

Experimental

Arm Title

Duloxetine 30 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase)

Intervention Type

Drug

Intervention Name(s)

fluoxetine

Other Intervention Name(s)

LY110140, Prozac

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

duloxetine

Other Intervention Name(s)

LY248686, Cymbalta

Intervention Description

60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)

Intervention Type

Drug

Intervention Name(s)

duloxetine

Other Intervention Name(s)

LY248686, Cymbalta

Intervention Description

30 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 10

Secondary Outcome Measure Information:

Title

Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint

Description

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. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.

Time Frame

Week 10, Week 36

Title

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

Description

Time Frame

Baseline, Week 10

Title

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

Description

Time Frame

Baseline, Week 10

Title

Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint

Description

Time Frame

Week 10, Week 36

Title

Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint

Description

Time Frame

Baseline, Week 10

Title

Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint

Description

Time Frame

Week 10, Week 36

Title

Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10

Description

Time Frame

Baseline through Week 10

Title

Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36

Description

Time Frame

Week 10 through Week 36

Title

Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10

Description

Time Frame

Baseline through Week 10

Title

Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36

Description

Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.

Time Frame

Week 10 through Week 36

Title

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

Description

Time Frame

Baseline through Week 10

Title

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

Description

Time Frame

Week 10 through Week 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Facility Name

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72223

Country

United States

Facility Name

City

Carson

State/Province

California

ZIP/Postal Code

90746

Country

United States

Facility Name

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

City

Imperial

State/Province

California

ZIP/Postal Code

92251

Country

United States

Facility Name

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

City

Middletown

State/Province

Connecticut

ZIP/Postal Code

06457

Country

United States

Facility Name

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33013

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

City

Oak Brook

State/Province

Illinois

ZIP/Postal Code

60523

Country

United States

Facility Name

City

Terre Haute

State/Province

Indiana

ZIP/Postal Code

47802

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

City

Glen Burnie

State/Province

Maryland

ZIP/Postal Code

21061

Country

United States

Facility Name

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

City

Clinton Twp

State/Province

Michigan

ZIP/Postal Code

48038

Country

United States

Facility Name

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73139

Country

United States

Facility Name

City

Salem

State/Province

Oregon

ZIP/Postal Code

97301

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19139

Country

United States

Facility Name

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

City

Dalllas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

City

Lake Jackson

State/Province

Texas

ZIP/Postal Code

77566

Country

United States

Facility Name

City

Wharton

State/Province

Texas

ZIP/Postal Code

77488

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

City

West Allis

State/Province

Wisconsin

ZIP/Postal Code

53227

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1058AAJ

Country

Argentina

Facility Name

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 1Z9

Country

Canada

Facility Name

City

Parry Sound

State/Province

Ontario

ZIP/Postal Code

P2A 3A4

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6J 3S3

Country

Canada

Facility Name

City

Aguascalientes

ZIP/Postal Code

20217

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44630

Country

Mexico

Facility Name

City

Leon

ZIP/Postal Code

37000

Country

Mexico

Facility Name

City

Merida

ZIP/Postal Code

97000

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

7810

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64710

Country

Mexico

Facility Name

City

Morelia

ZIP/Postal Code

58260

Country

Mexico

Facility Name

City

Tlalnepantla

ZIP/Postal Code

53160

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

25978741

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.

Results Reference

derived

PubMed Identifier

24815533

Citation

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.

Results Reference

derived

Learn more about this trial

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

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