Trial Outcomes & Findings for Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder (NCT NCT00529789)
NCT ID: NCT00529789
Last Updated: 2011-10-24
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Baseline to 18 weeks
Results posted on
2011-10-24
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Study Period II/III
STARTED
|
72
|
|
Study Period II/III
COMPLETED
|
48
|
|
Study Period II/III
NOT COMPLETED
|
24
|
|
Study Period IV
STARTED
|
48
|
|
Study Period IV
COMPLETED
|
42
|
|
Study Period IV
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Study Period II/III
Parent/Caregiver Decision
|
9
|
|
Study Period II/III
Adverse Event
|
3
|
|
Study Period II/III
Lack of Efficacy
|
2
|
|
Study Period II/III
Withdrawal by Subject
|
1
|
|
Study Period II/III
Protocol Violation
|
3
|
|
Study Period II/III
Physician Decision
|
3
|
|
Study Period II/III
Lost to Follow-up
|
3
|
|
Study Period IV
Parent/Caregiver Decision
|
1
|
|
Study Period IV
Adverse Event
|
1
|
|
Study Period IV
Lack of Efficacy
|
1
|
|
Study Period IV
Lost to Follow-up
|
3
|
Baseline Characteristics
Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Duloxetine
n=72 Participants
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.
|
|---|---|
|
Age Continuous
|
12.5 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
17 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
42 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
11 participants
n=5 Participants
|
|
Race/Ethnicity
Native American
|
1 participants
n=5 Participants
|
|
Tobacco Use
No
|
70 participants
n=5 Participants
|
|
Tobacco Use
Yes
|
1 participants
n=5 Participants
|
|
Tobacco Use
Not Available
|
1 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
23.7 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 18 weeksPopulation: All enrolled patients with data for specified category.
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).
Outcome measures
| Measure |
Duloxetine
n=72 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants With Emergence of Suicidal Ideation During Period II/III
|
2 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 0 and Between 18 and 30 WeeksPopulation: All enrolled patients with data for specified category.
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).
Outcome measures
| Measure |
Duloxetine
n=48 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants With Emergence of Suicidal Ideation During Period IV
|
0 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to 18 WeeksPopulation: All enrolled patients.
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.
Outcome measures
| Measure |
Duloxetine
n=72 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III
Completed suicide
|
0 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III
Non-fatal suicide event
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III
Worsening of Suicidal Ideation
|
1 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Between 18 and 30 WeeksPopulation: Number of enrolled patients with baseline and post-baseline values in 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.
Outcome measures
| Measure |
Duloxetine
n=45 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV
Completed suicide
|
0 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV
Non-fatal suicide event
|
0 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV
Worsening of Suicidal Ideation
|
1 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to 18 WeeksPopulation: Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.
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.
Outcome measures
| Measure |
Duloxetine
n=72 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III
High Diastolic Blood Pressure
|
22 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III
High Systolic Blood Pressure
|
25 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III
High Pulse
|
2 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Between 18 and 30 WeeksPopulation: Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.
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.
Outcome measures
| Measure |
Duloxetine
n=45 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV
High Diastolic Blood Pressure
|
3 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV
High Systolic Blood Pressure
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV
High Pulse
|
0 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to 18 WeeksPopulation: Total number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.
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).
Outcome measures
| Measure |
Duloxetine
n=72 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III
High Alanine Transaminase (N=69))
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III
High Creatine Phosphokinase (N=69)
|
6 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III
Low Glucose (N=69)
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III
Low Hematocrit (N=60)
|
8 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III
Low Hemoglobin (N=67)
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III
High Inorganic Phosphorus (N=62)
|
16 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III
Low Leukocyte Count (N=68)
|
1 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Between 18 and 30 WeeksPopulation: 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.
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).
Outcome measures
| Measure |
Duloxetine
n=48 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV
High Alkaline Phosphatase (N=42)
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV
Low Hematocrit (N=39)
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV
High Inorganic Phosphorus (N=39)
|
3 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to 18 WeeksPopulation: Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.
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.
Outcome measures
| Measure |
Duloxetine
n=72 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III
High QRS Interval (N=63)
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III
High QTc Bazette's Correction (N=64)
|
2 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III
High QTc Fredericia's Correction (N=65)
|
0 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Between 18 and 30 WeeksPopulation: Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.
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.
Outcome measures
| Measure |
Duloxetine
n=48 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV
High QRS Interval (N=39)
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV
High QTc Bazette's Correction (N=41)
|
1 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV
High QTc Fredericia's Correction (N=41)
|
0 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 10, 14, 18Population: Number of patients in each duloxetine dose.
Plasma samples were obtained at steady state, and approximately 95% of duloxetine concentrations were within the 24 hour dosing interval.
Outcome measures
| Measure |
Duloxetine
n=14 Participants
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.
|
Duloxetine Dose - 30 mg
n=53 Participants
30 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.
|
Duloxetine - 60 mg
n=41 Participants
60 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.
|
Duloxetine Dose - 90 mg
n=33 Participants
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.
|
Duloxetine - 120 mg
n=19 Participants
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.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Summary of Observed Duloxetine Plasma Concentrations Stratified by Duloxetine Dose
|
15.2 nanograms per milliliter (ng/mL)
Standard Deviation 12.0
|
20.8 nanograms per milliliter (ng/mL)
Standard Deviation 21.2
|
41.1 nanograms per milliliter (ng/mL)
Standard Deviation 34.7
|
57.6 nanograms per milliliter (ng/mL)
Standard Deviation 43.2
|
77.6 nanograms per milliliter (ng/mL)
Standard Deviation 54.6
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), 18 Weeks, 30 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Duloxetine
n=72 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)
18 Week Baseline (n=72)
|
4.5 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
|
Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)
18 Week Change from Baseline (n=72)
|
-2.11 units on a scale
Standard Deviation 1.17
|
—
|
—
|
—
|
—
|
|
Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)
30 Week Baseline (n=45)
|
4.5 units on a scale
Standard Deviation 0.59
|
—
|
—
|
—
|
—
|
|
Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)
30 Week Change from Baseline (n=45)
|
-2.7 units on a scale
Standard Deviation 1.07
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), 18 Weeks, 30 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Duloxetine
n=72 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
18 Week Baseline (n=72)
|
61.69 units on a scale
Standard Deviation 8.98
|
—
|
—
|
—
|
—
|
|
Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
18 Week Change from Baseline (n=72)
|
-32.11 units on a scale
Standard Deviation 12.92
|
—
|
—
|
—
|
—
|
|
Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
30 Week Baseline (n=45)
|
61.8 units on a scale
Standard Deviation 9.28
|
—
|
—
|
—
|
—
|
|
Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
30 Week Change from Baseline (n=45)
|
-38.8 units on a scale
Standard Deviation 11.14
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 (Baseline) to 30 WeeksPopulation: All enrolled patients.
A listing of adverse events leading to discontinuation from the study. Abbreviation in data table: ADHD = Attention-Deficit/Hyperactivity Disorder.
Outcome measures
| Measure |
Duloxetine
n=72 Participants
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.
|
Duloxetine Dose - 30 mg
30 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.
|
Duloxetine - 60 mg
60 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.
|
Duloxetine Dose - 90 mg
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.
|
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.
|
|---|---|---|---|---|---|
|
Adverse Events Leading to Discontinuation
Period II/III: Nausea
|
1 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events Leading to Discontinuation
Period II/III: Worsening of ADHD
|
1 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events Leading to Discontinuation
Period II/III: Rash
|
1 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events Leading to Discontinuation
Period IV: Irritability
|
1 participants
|
—
|
—
|
—
|
—
|
Adverse Events
Duloxetine - Period II/III
Serious events: 5 serious events
Other events: 57 other events
Deaths: 0 deaths
Duloxetine - Period IV
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine - Period II/III
n=72 participants at risk
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.
|
Duloxetine - Period IV
n=48 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
1/72 • Number of events 1 • 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.
|
0.00%
0/48 • 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.
|
|
Psychiatric disorders
Depression
|
1.4%
1/72 • Number of events 1 • 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.
|
0.00%
0/48 • 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.
|
|
Psychiatric disorders
Oppositional defiant disorder
|
1.4%
1/72 • Number of events 1 • 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.
|
0.00%
0/48 • 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.
|
|
Psychiatric disorders
Self injurious behaviour
|
2.8%
2/72 • Number of events 2 • 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.
|
0.00%
0/48 • 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.
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
1/72 • Number of events 1 • 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.
|
0.00%
0/48 • 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.
|
Other adverse events
| Measure |
Duloxetine - Period II/III
n=72 participants at risk
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.
|
Duloxetine - Period IV
n=48 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
1.4%
1/72 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Eye disorders
Myopia
|
1.4%
1/72 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
6/72 • Number of events 8 • 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.
|
0.00%
0/48 • 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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/72 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
2/72 • Number of events 2 • 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.
|
0.00%
0/48 • 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.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
4/72 • Number of events 4 • 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.
|
4.2%
2/48 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Flatulence
|
2.8%
2/72 • Number of events 2 • 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.
|
0.00%
0/48 • 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.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
18/72 • Number of events 20 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
13.9%
10/72 • Number of events 13 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
General disorders
Fatigue
|
6.9%
5/72 • Number of events 5 • 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.
|
4.2%
2/48 • Number of events 2 • 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.
|
|
General disorders
Irritability
|
2.8%
2/72 • Number of events 2 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Infections and infestations
Ear infection
|
2.8%
2/72 • Number of events 2 • 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.
|
0.00%
0/48 • 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.
|
|
Infections and infestations
Gastroenteritis viral
|
4.2%
3/72 • Number of events 3 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Infections and infestations
Influenza
|
4.2%
3/72 • Number of events 3 • 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.
|
0.00%
0/48 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
9/72 • Number of events 9 • 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.
|
0.00%
0/48 • 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.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.4%
1/72 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Infections and infestations
Sinusitis
|
2.8%
2/72 • Number of events 2 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
2/72 • Number of events 3 • 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.
|
0.00%
0/48 • 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.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.8%
2/72 • Number of events 2 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.2%
3/72 • Number of events 3 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Investigations
White blood cell count decreased
|
1.4%
1/72 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
4/72 • Number of events 4 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Obesity
|
1.4%
1/72 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Nervous system disorders
Dizziness
|
9.7%
7/72 • Number of events 7 • 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.
|
0.00%
0/48 • 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.
|
|
Nervous system disorders
Headache
|
13.9%
10/72 • Number of events 13 • 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.
|
0.00%
0/48 • 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.
|
|
Nervous system disorders
Migraine
|
1.4%
1/72 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Nervous system disorders
Sedation
|
9.7%
7/72 • Number of events 7 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Nervous system disorders
Somnolence
|
9.7%
7/72 • Number of events 8 • 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.
|
4.2%
2/48 • Number of events 2 • 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.
|
|
Nervous system disorders
Tremor
|
0.00%
0/72 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/72 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Psychiatric disorders
Anxiety
|
2.8%
2/72 • Number of events 2 • 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.
|
0.00%
0/48 • 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.
|
|
Psychiatric disorders
Bruxism
|
4.2%
3/72 • Number of events 3 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Psychiatric disorders
Insomnia
|
4.2%
3/72 • Number of events 3 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/72 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Psychiatric disorders
Oppositional defiant disorder
|
2.8%
2/72 • Number of events 2 • 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.
|
0.00%
0/48 • 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.
|
|
Psychiatric disorders
Restlessness
|
2.8%
2/72 • Number of events 2 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
1/72 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/72 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.4%
1/72 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
1.4%
1/72 • Number of events 1 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
3/72 • Number of events 3 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.2%
3/72 • Number of events 3 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.8%
2/72 • Number of events 2 • 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.
|
0.00%
0/48 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
4/72 • Number of events 5 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/72 • 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.
|
2.1%
1/48 • Number of events 1 • 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.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60