Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder

Eli Lilly and Company72 enrolled

Overview

The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily orally is tolerated and safe, in children (aged 7 through 11 years) and adolescents (aged 12 through 17 years) with Major Depressive Disorder.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

duloxetineDRUG

20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is \>40 kg, initial dose is 30 mg, then titrated up.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male / Female outpatients 7 to 17 years of age diagnosed with Major Depressive Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised \[CDRS-R\] with a total score greater than or equal to 40 at Visit 1, Visit 2, and Visit 3 and a Clinical Global Impressions of Severity \[CGI-Severity\] rating of greater than or equal to 4 at Visit 1, Visit 2, and Visit 3.) * Female patients must test negative on a pregnancy at visit 1. Exclusion Criteria: * Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or electrocardiogram (ECG) result, hypersensitivity to duloxetine, or to its inactive ingredients, frequent or severe allergic reactions to multiple medications, uncontrolled narrow-angle glaucoma, acute liver injury (for example, hepatitis) or severe cirrhosis (Child-Pugh Class C) that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study. * Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator. * Have a significant suicide attempt within 1 year of Visit 1 or have a score of 5 or greater on Item 13 (Suicidal Ideation) on the CDRS-R at Visit 1, Visit 2, or Visit 3, or are currently at risk of suicide in the opinion of the investigator. * Have a weight less than 20 kg at any Screening Phase visit. * Have previous exposure to duloxetine * Female patients who are either pregnant, nursing or have recently given birth.

Locations (22)

Outcomes

Primary Outcomes

Number of Participants With Emergence of Suicidal Ideation During Period II/III

Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0).

Time frame: Baseline to 18 weeks

Number of Participants With Emergence of Suicidal Ideation During Period IV

Time frame: Week 0 and Between 18 and 30 Weeks

Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III

The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.

Time frame: Baseline to 18 Weeks

Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV

Data from ClinicalTrials.gov

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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.

Dothan, Alabama, United States

Chandler, Arizona, United States

El Centro, California, United States

Gainesville, Florida, United States

Miami, Florida, United States

South Miami, Florida, United States

Eagle, Idaho, United States

Libertyville, Illinois, United States

Terre Haute, Indiana, United States

Overland Park, Kansas, United States

...and 12 more locations

Time frame: Between 18 and 30 Weeks

Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III

Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110.

Time frame: Baseline to 18 Weeks

Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV

Time frame: Between 18 and 30 Weeks

Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III

The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alanine transaminase (\>165 Units/Liter \[U/L\]); High Creatine Phosphokinase (females: \>507 U/L; males:\>594 U/L); Low Glucose (\<2.498 millimoles/L); Low Hematocrit (females: \<0.32; males \<0.37); Low Hemoglobin (females \<5.896 millimoles/L \[mmol/L\] iron; males \<7.137 mmol/L iron); High Inorganic Phosphorus (\>1.776 millimoles/L); Low Leukocyte Count (\<2.8 X10\^9/L).

Time frame: Baseline to 18 Weeks

Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV

The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alkaline Phosphatase (\>420 Units/Liter \[U/L\]); Low Hematocrit (females \<0.32; males \<0.37); High Inorganic Phosphorus (\>1.776 millimoles/L).

Time frame: Between 18 and 30 Weeks

Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III

Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec.

Time frame: Baseline to 18 Weeks

Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV

Time frame: Between 18 and 30 Weeks

Secondary Outcomes

Pharmacokinetics: Summary of Observed Duloxetine Plasma Concentrations Stratified by Duloxetine Dose

Plasma samples were obtained at steady state, and approximately 95% of duloxetine concentrations were within the 24 hour dosing interval.

Time frame: Weeks 2, 4, 6, 8, 10, 14, 18

Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.

Time frame: Week 0 (Baseline), 18 Weeks, 30 Weeks

Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score

Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression. Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.

Time frame: Week 0 (Baseline), 18 Weeks, 30 Weeks