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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-HMFN | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duloxetine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 18 weeks |
| 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). | 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. | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Leading to Discontinuation | A listing of adverse events leading to discontinuation from the study. Abbreviation in data table: ADHD = Attention-Deficit/Hyperactivity Disorder. | Week 0 (Baseline) to 30 Weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 36303 |
Period I was a 2-week Screening/Washout Phase. Period II was a 10-week Dose-Titrating with Pharmacokinetic Sampling Phase. Period III was an 8-week Safety and Tolerability Phase. Period IV was a 3-month Extended Safety and Tolerability Phase. Period V was a 2-week Taper Phase. Results presented are for combined Periods II/III and Period IV.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Period II/III |
|
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| 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. | Baseline to 18 Weeks |
| 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. | 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). | 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). | 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. | Baseline to 18 Weeks |
| 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. | Between 18 and 30 Weeks |
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. |
| 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. | Week 0 (Baseline), 18 Weeks, 30 Weeks |
| United States |
| 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. | Chandler | Arizona | 85226 | United States |
| 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. | El Centro | California | 92243 | United States |
| 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. | Gainesville | Florida | 32607 | United States |
| 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. | Miami | Florida | 33180 | United States |
| 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. | South Miami | Florida | 33143 | United States |
| 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. | Eagle | Idaho | 83616 | United States |
| 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. | Libertyville | Illinois | 60048 | United States |
| 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. | Terre Haute | Indiana | 47802 | United States |
| 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. | Overland Park | Kansas | 66211 | United States |
| 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. | Baton Rouge | Louisiana | 70816 | United States |
| 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. | Toms River | New Jersey | 08755 | United States |
| 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. | Mount Kisco | New York | 10549 | United States |
| 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. | Oklahoma City | Oklahoma | 73116 | United States |
| 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. | Memphis | Tennessee | 38117 | United States |
| 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. | Houston | Texas | 77057 | United States |
| 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. | Lake Jackson | Texas | 77566 | United States |
| 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. | San Antonio | Texas | 78247 | United States |
| 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. | Herndon | Virginia | 20170 | United States |
| 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. | Midlothian | Virginia | 23112 | United States |
| 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. | Norfolk | Virginia | 23505 | United States |
| 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. | Bellevue | Washington | 98004 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
| Study Period IV |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Race/Ethnicity | Number | participants |
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| Tobacco Use | Tobacco use was based on cotinine level. | Number | participants |
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| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/square meters (kg/m^2) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All enrolled patients with data for specified category. | Posted | Number | participants | Baseline to 18 weeks |
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| ||||||||||||||||||||||||||
| Primary | 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). | All enrolled patients with data for specified category. | Posted | Number | participants | Week 0 and Between 18 and 30 Weeks |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All enrolled patients. | Posted | Number | participants | Baseline to 18 Weeks |
|
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| Primary | 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 enrolled patients with baseline and post-baseline values in Period IV. | Posted | Number | participants | Between 18 and 30 Weeks |
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| Primary | 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 patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits. | Posted | Number | participants | Baseline to 18 Weeks |
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| Secondary | 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. | Number of patients in each duloxetine dose. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Weeks 2, 4, 6, 8, 10, 14, 18 |
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| Secondary | 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. | 18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Baseline), 18 Weeks, 30 Weeks |
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| Secondary | 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. | 18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Baseline), 18 Weeks, 30 Weeks |
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| Primary | 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 patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits. | Posted | Number | participants | Between 18 and 30 Weeks |
|
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| Primary | 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). | Total number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits. | Posted | Number | participants | Baseline to 18 Weeks |
|
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| Primary | 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). | Total number of patients with baseline (and none abnormal) and post-baseline values in Period IV, based on all values at scheduled and unscheduled visits. | Posted | Number | participants | Between 18 and 30 Weeks |
|
| |||||||||||||||||||||||||||
| Primary | 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 patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits. | Posted | Number | participants | Baseline to 18 Weeks |
|
| |||||||||||||||||||||||||||
| Primary | 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. | Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits. | Posted | Number | participants | Between 18 and 30 Weeks |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Adverse Events Leading to Discontinuation | A listing of adverse events leading to discontinuation from the study. Abbreviation in data table: ADHD = Attention-Deficit/Hyperactivity Disorder. | All enrolled patients. | Posted | Number | participants | Week 0 (Baseline) to 30 Weeks |
|
|
Duloxetine - Period II/III: Week 0 (Baseline) to Week 18; Duloxetine - Period IV: Week 18 to Week 30
In the opinion of the investigator, none of the Serious Adverse Events were considered related to the study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duloxetine - Period II/III | 20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 18 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. | 5 | 72 | 57 | 72 | ||
| EG001 | Duloxetine - Period IV | 20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) between Weeks 18 - 30; 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. | 0 | 48 | 21 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oppositional defiant disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Self injurious behaviour | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Bruxism | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Libido increased | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oppositional defiant disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Menstruation delayed | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
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| Asthma exercise induced | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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The Results Record was revised as a result of correcting identified errors in the number of participants with potentially significant changes in blood pressure.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Lost to Follow-up |
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| East Asian |
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| Hispanic |
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| Native American |
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| Not Available |
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90 milligrams (mg) every day (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up. |
| OG004 | Duloxetine - 120 mg | 120 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up. |
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