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Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00962104
First received: August 18, 2009
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
Results First Received: February 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: Atomoxetine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Atomoxetine Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
Placebo Taken by mouth, once daily for 10 weeks.

Participant Flow:   Overall Study
    Atomoxetine     Placebo  
STARTED     195     196  
Full Analysis Set     193 [1]   195 [2]
COMPLETED     155     171  
NOT COMPLETED     40     25  
Adverse Event                 10                 3  
Entry Criteria Not Met                 1                 2  
Lack of Efficacy                 0                 1  
Lost to Follow-up                 10                 4  
Physician Decision                 1                 0  
Protocol Violation                 6                 8  
Sponsor Decision                 0                 1  
Withdrawal by Subject                 10                 6  
Unknown                 2                 0  
[1] 2 participants were excluded because they failed to take the assigned study medication.
[2] 1 participant was excluded because that participant failed to take the assigned study medication.



  Baseline Characteristics
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Reporting Groups
  Description
Atomoxetine Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
Placebo Taken by mouth, once daily for 10 weeks.
Total Total of all reporting groups

Baseline Measures
    Atomoxetine     Placebo     Total  
Number of Participants  
[units: participants]
 		  193     195     388  
Age  
[units: years]
Mean ± Standard Deviation 		  32.8  ± 8.1     31.7  ± 7.8     32.3  ± 8.0  
Gender  
[units: participants]
 		     
Female     103     100     203  
Male     90     95     185  
Race/Ethnicity, Customized  
[units: participants]
 		     
Asian     193     195     388  
Region of Enrollment  
[units: participants]
 		     
Taiwan     34     34     68  
Japan     123     124     247  
Korea, Republic of     36     37     73  
Number of Participants with the Cytochrome P450 2D6 (CYP2D6) Genotype [1]
[units: participants]
 		     
Extensive metabolizer (EM)     40     45     85  
Intermediate metabolizer (IM)     137     137     274  
Poor metabolizer (PM)     0     0     0  
Ultra-rapid metabolizer (UM)     4     2     6  
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype Current [2]
[units: participants]
 		     
Inattentive     96     95     191  
Hyperactive/Impulsive     4     4     8  
Combined     93     96     189  
Prior Stimulant Exposure Status  
[units: participants]
 		     
Prior Stimulant Exposure - Yes     43     42     85  
Prior Stimulant Exposure - No     150     153     303  
Current Major Depressive Episode Status [3]
[units: participants]
 		     
Major Depressive Episode - Yes     4     0     4  
Major Depressive Episode - No     189     195     384  
Recurrent Major Depressive Episode Status [4]
[units: participants]
 		     
Recurrent Major Depressive Episode - Yes     1     0     1  
Recurrent Major Depressive Episode - No     192     195     387  
Current Major Depressive Episode with Melancholic Features Status [5]
[units: participants]
 		     
Current Major Depressive Episode with - Yes     2     0     2  
Current Major Depressive Episode with - No     191     195     386  
Current Social Phobia (Social Anxiety Disorder [SAD]) Status [6]
[units: participants]
 		     
Current Social Phobia (SAD) - Yes     3     4     7  
Current Social Phobia (SAD) - No     190     191     381  
Obsessive-Compulsive Disorder (OCD) Status [7]
[units: participants]
 		     
Current OCD - Yes     1     2     3  
Current OCD - No     192     193     385  
Conners' Adult Attention-Deficit Hyperactivity/Disorder Rating Scale-Investigator Rated: Screening V [8]
[units: units on a scale]
Mean ± Standard Deviation 		  33.2  ± 7.7     33.9  ± 7.5     33.6  ± 7.6  
[1] Genotype characterization was used to determine participants' metabolic status. The number of participants differs from the overall number of baseline participants because either cytochrome P450 2D6 (CYP2D6) was not collected or was not evaluated due to an error.
[2] ADHD subtype was classified by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria.
[3] Current (past 2 weeks) major depressive episode status was assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview that assesses psychiatric disorders.
[4] Recurrent major depressive episode status was assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview that assesses psychiatric disorders.
[5] Current (past 2 weeks) major depressive episode with melancholic features status was assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview that assesses psychiatric disorders.
[6] Current (past month) social phobia (SAD) status was assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview that assesses psychiatric disorders.
[7] Current (past month) OCD status was assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview that assesses psychiatric disorders.
[8] Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. Higher scores indicate greater impairment.



  Outcome Measures
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1.  Primary:   Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks   [ Time Frame: Baseline, up to 10 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks   [ Time Frame: Baseline, up to 10 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks   [ Time Frame: Baseline, up to 10 weeks ]
  Show Outcome Measure 3

4.  Secondary:   The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks   [ Time Frame: 10 weeks ]
  Show Outcome Measure 4

5.  Secondary:   The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version (CAARS-S:SV) 18 Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks   [ Time Frame: 10 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks   [ Time Frame: Baseline, up to 10 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks   [ Time Frame: Baseline, up to 10 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks   [ Time Frame: Baseline, up to 10 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks   [ Time Frame: Up to 10 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks   [ Time Frame: Baseline, up to 10 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in the Hamilton Depression Rating Scale-17 Items (HAMD-17 Total) up to 10 Weeks   [ Time Frame: Baseline, up to 10 weeks ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications:


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00962104     History of Changes
Other Study ID Numbers: 12107, B4Z-JE-LYEE
Study First Received: August 18, 2009
Results First Received: February 6, 2012
Last Updated: August 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare