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Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD) (ADHD SWITCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00760747
Recruitment Status : Completed
First Posted : September 26, 2008
Results First Posted : September 1, 2011
Last Update Posted : September 1, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Atomoxetine
Enrollment 112
Recruitment Details  
Pre-assignment Details Study Period II was a 10-week treatment period. Study Period III was a 4-week period, during which participants continued on atomoxetine treatment in the same dose as given at the end of Study Period II or in a higher dose, up to a maximum of 1.8 mg/kg/day.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks. Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Period Title: Study Period II
Started 57 55
Received at Least One Dose of Study Drug 57 54
Completed 44 41
Not Completed 13 14
Reason Not Completed
Adverse Event             3             4
Lack of Efficacy             0             6
Parent/Caregiver Decision             3             0
Protocol Violation             6             3
Withdrawal by Subject             1             0
No drug administered             0             1
Period Title: Study Period III
Started 44 41
Completed 41 38
Not Completed 3 3
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             1             0
Parent/Caregiver Decision             0             1
Protocol Violation             1             1
Physician Decision             0             1
Arm/Group Title Slow Switching Group Fast Switching Group Total
Hide Arm/Group Description Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks. Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks. Total of all reporting groups
Overall Number of Baseline Participants 57 54 111
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 54 participants 111 participants
11.1  (2.51) 12.0  (2.16) 11.5  (2.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 111 participants
Female
8
  14.0%
10
  18.5%
18
  16.2%
Male
49
  86.0%
44
  81.5%
93
  83.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 111 participants
Caucasian 46 43 89
African 1 0 1
Hispanic 10 11 21
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 111 participants
Mexico 10 10 20
Australia 7 5 12
United Kingdom 8 7 15
Spain 29 28 57
Portugal 3 4 7
Attention Deficit Hyperactivity Disorder (ADHD) subtype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 54 participants 111 participants
Combined 38 36 74
Hyperactive/Impulsive 1 3 4
Inattentive 17 15 32
Not otherwise categorized 1 0 1
[1]
Measure Description: ADHD subtype was classified by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria.
1.Primary Outcome
Title Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint
Hide Description Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-14.3  (1.2) -15.0  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Slow Switching Group, Fast Switching Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.692
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean differences at week 10
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-4.0 to 2.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.7
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint
Hide Description Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time Frame Baseline, 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.0  (1.0) -8.1  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Slow Switching Group, Fast Switching Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.927
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean differences at week 2
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.9 to 2.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint
Hide Description The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.6  (0.2) -0.4  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Slow Switching Group, Fast Switching Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.456
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean differences at week 10
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.3 to 0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint
Hide Description The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.0  (0.2) -0.8  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Slow Switching Group, Fast Switching Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.517
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean differences at week 10
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.3 to 0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint
Hide Description The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.3  (0.2) -1.2  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Slow Switching Group, Fast Switching Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean differences at week 10
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint
Hide Description The CGI- S is a single-item clinician rating of the severity of the participant’s ADHD symptoms in relation to the clinician’s total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.7  (0.2) -1.7  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Slow Switching Group, Fast Switching Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.898
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean differences at week 10
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.4 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint
Hide Description CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score– Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Least Squares Mean (Standard Error)
Unit of Measure: standard deviation units
Satisfaction Domain 3.4  (1.6) 2.2  (1.6)
Comfort Domain 0.7  (1.2) 4.1  (1.1)
Risk Avoidance Domain 4.9  (1.4) 2.9  (1.4)
Resilience Domain 1.8  (1.4) -1.0  (1.4)
Achievement Domain 3.5  (1.7) -1.2  (1.6)
8.Secondary Outcome
Title Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint
Hide Description The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported.
Time Frame Baseline, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment. Last Observation Carried Forward (LOCF).
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (1.16) -0.5  (1.11)
9.Secondary Outcome
Title Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 6 weeks, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Mean (Standard Deviation)
Unit of Measure: mmHg
Week 6 Change Diastolic BP (n=52, 52) 1.5  (7.21) 1.9  (8.31)
Week 6 Change Systolic BP (n=52, 52) 1.2  (7.74) 0.5  (9.05)
Week 14 Change Diastolic BP (n=43, 40) 2.3  (7.58) 3.1  (7.04)
Week 14 Change Systolic BP (n= 43, 40) -0.2  (8.62) 2.6  (9.00)
10.Secondary Outcome
Title Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 6 weeks, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Mean (Standard Deviation)
Unit of Measure: beats per minute
Week 6 Change (n=52, 52) 6.8  (11.12) 4.2  (8.83)
Week 14 Change (n=43, 40) 3.4  (12.69) 5.9  (10.17)
11.Secondary Outcome
Title Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 6 weeks, 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Mean (Standard Deviation)
Unit of Measure: kilogram
Week 6 Change (n=52, 52) -0.4  (1.12) 0.6  (1.25)
Week 14 Change (n=43, 40) 0.6  (1.64) 1.1  (2.15)
12.Secondary Outcome
Title Number of Participants With Suicidal Behaviors and Ideations
Hide Description Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. 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, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Time Frame Baseline through 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description:
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Overall Number of Participants Analyzed 57 54
Measure Type: Number
Unit of Measure: participants
1 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Slow Switching Group Fast Switching Group
Hide Arm/Group Description Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks. Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
All-Cause Mortality
Slow Switching Group Fast Switching Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Slow Switching Group Fast Switching Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/57 (1.75%)      1/54 (1.85%)    
Nervous system disorders     
VIth nerve paralysis  1  1/57 (1.75%)  1 0/54 (0.00%)  0
Psychiatric disorders     
Suicide attempt  1  0/57 (0.00%)  0 1/54 (1.85%)  1
Skin and subcutaneous tissue disorders     
Rash  1  1/57 (1.75%)  1 0/54 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Slow Switching Group Fast Switching Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/57 (61.40%)      30/54 (55.56%)    
Gastrointestinal disorders     
Abdominal pain  1  3/57 (5.26%)  3 6/54 (11.11%)  13
Abdominal pain upper  1  8/57 (14.04%)  11 5/54 (9.26%)  5
Nausea  1  4/57 (7.02%)  4 0/54 (0.00%)  0
Vomiting  1  1/57 (1.75%)  1 5/54 (9.26%)  6
General disorders     
Fatigue  1  3/57 (5.26%)  3 4/54 (7.41%)  4
Irritability  1  4/57 (7.02%)  5 3/54 (5.56%)  3
Pyrexia  1  4/57 (7.02%)  4 2/54 (3.70%)  3
Infections and infestations     
Nasopharyngitis  1  7/57 (12.28%)  8 3/54 (5.56%)  3
Upper respiratory tract infection  1  3/57 (5.26%)  3 0/54 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  11/57 (19.30%)  12 7/54 (12.96%)  7
Nervous system disorders     
Headache  1  11/57 (19.30%)  16 12/54 (22.22%)  19
Somnolence  1  4/57 (7.02%)  4 9/54 (16.67%)  9
Psychiatric disorders     
Insomnia  1  1/57 (1.75%)  1 3/54 (5.56%)  3
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/57 (5.26%)  4 1/54 (1.85%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00760747     History of Changes
Other Study ID Numbers: 12305
B4Z-EW-LYFJ ( Other Identifier: Eli Lilly and Company )
First Submitted: September 25, 2008
First Posted: September 26, 2008
Results First Submitted: August 2, 2011
Results First Posted: September 1, 2011
Last Update Posted: September 1, 2011