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Trial record 76 of 113 for:    centurion

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

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ClinicalTrials.gov Identifier: NCT00849901
Recruitment Status : Completed
First Posted : February 24, 2009
Results First Posted : March 6, 2012
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: duloxetine
Drug: Placebo
Drug: fluoxetine
Enrollment 337
Recruitment Details  
Pre-assignment Details This study consisted of a 10-week acute treatment phase, and a 6-month extension phase.
Arm/Group Title Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
Hide Arm/Group Description Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
Period Title: Acute Treatment Phase
Started 117 117 103
Completed 87 [1] 91 87 [2]
Not Completed 30 26 16
Reason Not Completed
Adverse Event             9             1             3
Lost to Follow-up             2             4             1
Protocol Violation             0             2             1
Withdrawal by Subject             4             10             4
Parent or Caregiver Decision             11             5             4
Physician Decision             1             1             1
Sponsor Decision             1             0             0
Lack of Efficacy             2             3             2
[1]
4 didn't enter extension phase.
[2]
1 didn't enter extension phase.
Period Title: Extension Phase
Started 83 91 86
Completed 56 65 69
Not Completed 27 26 17
Reason Not Completed
Adverse Event             2             8             4
Lost to Follow-up             3             0             1
Protocol Violation             2             2             4
Withdrawal by Subject             7             6             3
Parent or Caregiver Decision             10             4             4
Physician Decision             1             2             0
Lack of Efficacy             2             4             1
Arm/Group Title Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine Total
Hide Arm/Group Description Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase Total of all reporting groups
Overall Number of Baseline Participants 117 117 103 337
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 117 participants 117 participants 103 participants 337 participants
13.14  (3.043) 13.08  (3.272) 13.28  (3.055) 13.16  (3.120)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 117 participants 103 participants 337 participants
Female
64
  54.7%
61
  52.1%
51
  49.5%
176
  52.2%
Male
53
  45.3%
56
  47.9%
52
  50.5%
161
  47.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants 117 participants 103 participants 337 participants
American Indian or Alaska Native 1 1 1 3
Asian 0 2 0 2
Black or African American 17 9 13 39
White 90 93 79 262
Multiracial 4 7 5 16
Not Provided 5 5 5 15
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants 117 participants 103 participants 337 participants
United States 50 45 45 140
Finland 1 4 0 5
France 3 2 3 8
Germany 1 1 2 4
Slovakia 2 3 1 6
Ukraine 25 23 18 66
Russian Federation 13 15 12 40
Estonia 1 0 0 1
South Africa 21 24 22 67
Children's Depression Rating Scale-Revised (CDRS-R) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 117 participants 117 participants 103 participants 337 participants
59.2  (10.45) 58.8  (10.56) 60.2  (11.67) 59.4  (10.85)
[1]
Measure Description: CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression.
CDRS-R Subscale Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 117 participants 117 participants 103 participants 337 participants
Mood 16.3  (3.54) 15.9  (3.85) 16.1  (3.59) 16.1  (3.66)
Somatic 19.8  (4.54) 19.7  (4.21) 20.0  (4.75) 19.8  (4.48)
Subjective 10.1  (3.08) 10.4  (3.24) 10.4  (3.46) 10.3  (3.25)
Behavior 13.0  (2.79) 12.8  (2.87) 13.5  (3.00) 13.1  (2.89)
[1]
Measure Description: CDRS-R Subscale score include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21.
Clinical Global Impressions of Severity (CGI-Severity) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 117 participants 117 participants 103 participants 337 participants
4.5  (0.62) 4.5  (0.58) 4.6  (0.65) 4.5  (0.62)
[1]
Measure Description: CGI-Severity score evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
1.Primary Outcome
Title Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
Hide Description CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with both a baseline and at least one post-baseline value.
Arm/Group Title Duloxetine Fluoxetine Placebo
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
Received placebo PO, QD during acute treatment phase
Overall Number of Participants Analyzed 113 113 103
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-24.3  (1.09) -23.7  (1.06) -24.3  (1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint
Hide Description CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.
Time Frame Week 10, Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with value during treatment phase and at least one post-Week 10 value.
Arm/Group Title Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
Overall Number of Participants Analyzed 81 91 85
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.2  (0.86) -9.9  (0.72) -9.6  (0.86)
3.Secondary Outcome
Title Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint
Hide Description CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with both a baseline and at least one post-baseline value.
Arm/Group Title Duloxetine Fluoxetine Placebo
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
Received placebo PO, QD during acute treatment phase
Overall Number of Participants Analyzed 113 113 103
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Mood (N=113, 113, 103) -7.0  (0.36) -7.1  (0.35) -7.0  (0.37)
Somatic (N=113, 113, 103) -7.7  (0.42) -7.6  (0.41) -7.7  (0.42)
Subjective (N=113, 113, 103) -4.0  (0.23) -3.6  (0.22) -4.0  (0.23)
Behavior (N=113, 112, 103) -5.6  (0.30) -5.4  (0.30) -5.7  (0.31)
4.Secondary Outcome
Title Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint
Hide Description CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.
Time Frame Week 10, Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with value during treatment phase and at least one post-Week 10 value.
Arm/Group Title Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
Overall Number of Participants Analyzed 81 91 85
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Mood -1.9  (0.34) -2.5  (0.24) -2.9  (0.29)
Somatic -2.8  (0.35) -3.6  (0.27) -3.2  (0.33)
Subjective -0.3  (0.24) -1.3  (0.13) -1.2  (0.17)
Behavior -1.9  (0.23) -2.8  (0.20) -2.1  (0.36)
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint
Hide Description CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with both a baseline and at least one post-baseline value.
Arm/Group Title Duloxetine Fluoxetine Placebo
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
Received placebo PO, QD during acute treatment phase
Overall Number of Participants Analyzed 113 113 110
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.9  (0.11) -1.8  (0.10) -1.9  (0.11)
6.Secondary Outcome
Title Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint
Hide Description CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.
Time Frame Week 10, Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with value during treatment phase and at least one post-Week 10 value.
Arm/Group Title Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
Overall Number of Participants Analyzed 81 91 85
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.6  (0.12) -1.0  (0.07) -1.1  (0.10)
7.Secondary Outcome
Title Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10
Hide Description Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 - 0).
Time Frame Baseline through Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.
Arm/Group Title Duloxetine Fluoxetine Placebo
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
Received placebo PO, QD during acute treatment phase
Overall Number of Participants Analyzed 113 113 103
Measure Type: Number
Unit of Measure: participants
Suicidal Ideation 16 16 15
Suicidal Behavior 0 1 0
Treatment Emergent Suicidal Ideation 8 9 7
8.Secondary Outcome
Title Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36
Hide Description Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10).
Time Frame Week 10 through Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.
Arm/Group Title Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
Overall Number of Participants Analyzed 81 91 85
Measure Type: Number
Unit of Measure: participants
Suicidal Ideation 13 13 8
Suicidal Behavior 1 1 0
Treatment Emergent Suicidal Ideation 9 13 8
9.Secondary Outcome
Title Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10
Hide Description Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.
Time Frame Baseline through Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with normal ALT value (ALT <1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.
Arm/Group Title Duloxetine Fluoxetine Placebo
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
Received placebo PO, QD during acute treatment phase
Overall Number of Participants Analyzed 101 102 94
Measure Type: Number
Unit of Measure: participants
ALT≥3 x ULN 0 0 0
ALT≥5 x ULN 0 0 0
ALT≥10 x ULN 0 0 0
ALT≥3 x ULN and Total Bilirubin≥2 x ULN 0 0 0
10.Secondary Outcome
Title Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36
Hide Description Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.
Time Frame Week 10 through Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.
Arm/Group Title Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
Overall Number of Participants Analyzed 77 83 82
Measure Type: Number
Unit of Measure: participants
ALT≥3 x ULN 0 1 0
ALT≥5 x ULN 0 1 0
ALT≥10 x ULN 0 0 0
ALT≥3 x ULN and Total Bilirubin≥2 x ULN 0 0 0
11.Secondary Outcome
Title Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10
Hide Description PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.
Time Frame Baseline through Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.
Arm/Group Title Duloxetine Fluoxetine Placebo
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
Received placebo PO, QD during acute treatment phase
Overall Number of Participants Analyzed 117 117 103
Measure Type: Number
Unit of Measure: percentage of participants
Diastolic BP Increase (N=102, 106, 93) 8.8 7.5 17.2
Systolic BP Increase (N=100, 106, 90) 7.0 5.7 6.7
Pulse Decrease (N=111, 112, 102) 0.9 0.9 1.0
Pulse Increase (N=113, 114, 103) 0 0 1
Weight Decrease (N=113, 114, 103) 12.4 11.4 4.9
12.Secondary Outcome
Title Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36
Hide Description PCS increase in systolic and diastolic BP was defined as increase of ≥ 5mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.
Time Frame Week 10 through Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with normal value at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.
Arm/Group Title Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
Hide Arm/Group Description:
Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
Overall Number of Participants Analyzed 83 91 86
Measure Type: Number
Unit of Measure: percentage of participants
Diastolic BP Increase (N=65, 76, 61) 16.9 11.8 4.9
Systolic BP Increase (N=64, 80, 69) 12.5 12.5 10.1
Pulse Decrease (N=78, 84, 82) 0 0 0
Pulse Increase (N=81, 91, 84) 0 0 0
Weight Decrease (N=81, 91, 85) 6.2 3.3 9.4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine - Acute Fluoxetine - Acute Placebo - Acute Duloxetine - Extension Fluoxetine - Extension Placebo/Duloxetine - Extension
Hide Arm/Group Description Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase Received placebo PO, QD during acute treatment phase Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase Received fluoxetine 20 and/or 40 mg PO, QD during extension phase. One participant had discontinued the acute phase due to an adverse event but was accidentally dispensed drug at the last visit of the acute phase, thus based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs) (resulting in one more participant being analyzed for AEs than started the extension phase in the Participant Flow section). Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
All-Cause Mortality
Duloxetine - Acute Fluoxetine - Acute Placebo - Acute Duloxetine - Extension Fluoxetine - Extension Placebo/Duloxetine - Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine - Acute Fluoxetine - Acute Placebo - Acute Duloxetine - Extension Fluoxetine - Extension Placebo/Duloxetine - Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/117 (2.56%)      2/117 (1.71%)      1/103 (0.97%)      1/83 (1.20%)      4/92 (4.35%)      4/86 (4.65%)    
Blood and lymphatic system disorders             
Lymphadenitis  1  0/117 (0.00%)  0 1/117 (0.85%)  1 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 0/86 (0.00%)  0
Gastrointestinal disorders             
Gastritis  1  0/117 (0.00%)  0 1/117 (0.85%)  1 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 0/86 (0.00%)  0
Infections and infestations             
Pilonidal cyst  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 1/86 (1.16%)  1
Pneumonia  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 1/83 (1.20%)  1 0/92 (0.00%)  0 0/86 (0.00%)  0
Injury, poisoning and procedural complications             
Intentional overdose  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 1/92 (1.09%)  1 0/86 (0.00%)  0
Ulna fracture  1  0/117 (0.00%)  0 1/117 (0.85%)  1 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 0/86 (0.00%)  0
Nervous system disorders             
Convulsion  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 1/92 (1.09%)  1 0/86 (0.00%)  0
Epilepsy  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 1/92 (1.09%)  1 0/86 (0.00%)  0
Syncope  1  1/117 (0.85%)  1 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 0/86 (0.00%)  0
Psychiatric disorders             
Adjustment disorder with disturbance of conduct  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 1/92 (1.09%)  1 0/86 (0.00%)  0
Conversion disorder  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 1/86 (1.16%)  1
Drug abuse  1  1/117 (0.85%)  1 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 0/86 (0.00%)  0
Hypomania  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 1/92 (1.09%)  1 0/86 (0.00%)  0
Major depression  1  0/117 (0.00%)  0 0/117 (0.00%)  0 1/103 (0.97%)  1 0/83 (0.00%)  0 0/92 (0.00%)  0 1/86 (1.16%)  1
Panic attack  1  1/117 (0.85%)  1 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 0/86 (0.00%)  0
Restlessness  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 1/86 (1.16%)  1
Social phobia  1  1/117 (0.85%)  1 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 0/86 (0.00%)  0
Suicidal ideation  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 0/92 (0.00%)  0 1/86 (1.16%)  1
Suicide attempt  1  0/117 (0.00%)  0 0/117 (0.00%)  0 0/103 (0.00%)  0 0/83 (0.00%)  0 1/92 (1.09%)  1 0/86 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Duloxetine - Acute Fluoxetine - Acute Placebo - Acute Duloxetine - Extension Fluoxetine - Extension Placebo/Duloxetine - Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/117 (59.83%)      72/117 (61.54%)      68/103 (66.02%)      53/83 (63.86%)      56/92 (60.87%)      60/86 (69.77%)    
Gastrointestinal disorders             
Abdominal pain  1  1/117 (0.85%)  1 2/117 (1.71%)  2 5/103 (4.85%)  5 1/83 (1.20%)  1 2/92 (2.17%)  2 1/86 (1.16%)  1
Abdominal pain upper  1  4/117 (3.42%)  4 5/117 (4.27%)  7 7/103 (6.80%)  8 1/83 (1.20%)  1 2/92 (2.17%)  2 7/86 (8.14%)  7
Diarrhoea  1  6/117 (5.13%)  6 2/117 (1.71%)  2 2/103 (1.94%)  2 3/83 (3.61%)  3 4/92 (4.35%)  4 2/86 (2.33%)  2
Nausea  1  20/117 (17.09%)  28 15/117 (12.82%)  17 11/103 (10.68%)  14 3/83 (3.61%)  6 7/92 (7.61%)  8 12/86 (13.95%)  17
Vomiting  1  7/117 (5.98%)  7 6/117 (5.13%)  7 3/103 (2.91%)  3 4/83 (4.82%)  5 5/92 (5.43%)  5 8/86 (9.30%)  9
General disorders             
Fatigue  1  8/117 (6.84%)  8 3/117 (2.56%)  5 5/103 (4.85%)  5 1/83 (1.20%)  1 3/92 (3.26%)  3 4/86 (4.65%)  4
Infections and infestations             
Gastroenteritis  1  0/117 (0.00%)  0 1/117 (0.85%)  1 2/103 (1.94%)  2 4/83 (4.82%)  4 2/92 (2.17%)  2 3/86 (3.49%)  3
Influenza  1  7/117 (5.98%)  7 3/117 (2.56%)  3 6/103 (5.83%)  8 5/83 (6.02%)  6 3/92 (3.26%)  3 4/86 (4.65%)  4
Nasopharyngitis  1  2/117 (1.71%)  2 4/117 (3.42%)  4 5/103 (4.85%)  5 9/83 (10.84%)  9 8/92 (8.70%)  12 9/86 (10.47%)  9
Sinusitis  1  1/117 (0.85%)  1 1/117 (0.85%)  1 3/103 (2.91%)  3 4/83 (4.82%)  4 1/92 (1.09%)  1 1/86 (1.16%)  1
Upper respiratory tract infection  1  4/117 (3.42%)  4 3/117 (2.56%)  3 1/103 (0.97%)  1 5/83 (6.02%)  6 5/92 (5.43%)  7 3/86 (3.49%)  3
Injury, poisoning and procedural complications             
Incorrect dose administered  1  2/117 (1.71%)  2 4/117 (3.42%)  5 3/103 (2.91%)  3 4/83 (4.82%)  5 3/92 (3.26%)  3 0/86 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite  1  10/117 (8.55%)  11 10/117 (8.55%)  10 7/103 (6.80%)  7 2/83 (2.41%)  3 0/92 (0.00%)  0 3/86 (3.49%)  3
Nervous system disorders             
Dizziness  1  10/117 (8.55%)  11 4/117 (3.42%)  4 3/103 (2.91%)  3 3/83 (3.61%)  3 3/92 (3.26%)  3 6/86 (6.98%)  6
Headache  1  19/117 (16.24%)  23 18/117 (15.38%)  22 9/103 (8.74%)  10 9/83 (10.84%)  10 9/92 (9.78%)  10 10/86 (11.63%)  12
Somnolence  1  7/117 (5.98%)  7 6/117 (5.13%)  6 6/103 (5.83%)  6 2/83 (2.41%)  2 4/92 (4.35%)  5 3/86 (3.49%)  4
Psychiatric disorders             
Insomnia  1  6/117 (5.13%)  8 6/117 (5.13%)  6 2/103 (1.94%)  2 0/83 (0.00%)  0 0/92 (0.00%)  0 1/86 (1.16%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00849901     History of Changes
Other Study ID Numbers: 6223
F1J-MC-HMCK ( Other Identifier: Eli Lilly and Company )
First Submitted: February 20, 2009
First Posted: February 24, 2009
Results First Submitted: February 22, 2012
Results First Posted: March 6, 2012
Last Update Posted: September 11, 2017