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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
duloxetine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 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.

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine

Arm Description

Outcomes

Primary Outcome Measures

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).
Number of Participants With Emergence of Suicidal Ideation During Period IV
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).
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.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV
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.
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.
Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV
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.
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).
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).
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.
Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 12, 2007
Last Updated
October 18, 2011
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00529789
Brief Title
Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder
Official Title
F1J-MC-HMFN (a) An Open-Label Study of Tolerability, Safety, and Pharmacokinetics of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
duloxetine
Other Intervention Name(s)
LY248686, Cymbalta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Emergence of Suicidal Ideation During Period II/III
Description
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
Title
Number of Participants With Emergence of Suicidal Ideation During Period IV
Description
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
Week 0 and Between 18 and 30 Weeks
Title
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III
Description
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
Title
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV
Description
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
Between 18 and 30 Weeks
Title
Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III
Description
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
Title
Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV
Description
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
Between 18 and 30 Weeks
Title
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III
Description
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
Title
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV
Description
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
Title
Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III
Description
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
Title
Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV
Description
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
Between 18 and 30 Weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Summary of Observed Duloxetine Plasma Concentrations Stratified by Duloxetine Dose
Description
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
Title
Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)
Description
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
Title
Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
Description
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
Other Pre-specified Outcome Measures:
Title
Adverse Events Leading to Discontinuation
Description
A listing of adverse events leading to discontinuation from the study. Abbreviation in data table: ADHD = Attention-Deficit/Hyperactivity Disorder.
Time Frame
Week 0 (Baseline) to 30 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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 9AM-5PM Eastern Standard 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
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
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
Chandler
State/Province
Arizona
ZIP/Postal Code
85226
Country
United States
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
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
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
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
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
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
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
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
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
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
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
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
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
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
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
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
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
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70816
Country
United States
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
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
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
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
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
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
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
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
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
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
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
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78247
Country
United States
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
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
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
Midlothian
State/Province
Virginia
ZIP/Postal Code
23112
Country
United States
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
Norfolk
State/Province
Virginia
ZIP/Postal Code
23505
Country
United States
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
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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