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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
Results First Received: February 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 
Other                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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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 
[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.
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype Current [1] 
[Units: Participants]
     
Inattentive   96   95   191 
Hyperactive/Impulsive   4   4   8 
Combined   93   96   189 
[1] ADHD subtype was classified by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria.
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 [1] 
[Units: Participants]
     
Major Depressive Episode - Yes   4   0   4 
Major Depressive Episode - No   189   195   384 
[1] 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.
Recurrent Major Depressive Episode Status [1] 
[Units: Participants]
     
Recurrent Major Depressive Episode - Yes   1   0   1 
Recurrent Major Depressive Episode - No   192   195   387 
[1] Recurrent major depressive episode status was assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview that assesses psychiatric disorders.
Current Major Depressive Episode with Melancholic Features Status [1] 
[Units: Participants]
     
Current Major Depressive Episode with - Yes   2   0   2 
Current Major Depressive Episode with - No   191   195   386 
[1] 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.
Current Social Phobia (Social Anxiety Disorder [SAD]) Status [1] 
[Units: Participants]
     
Current Social Phobia (SAD) - Yes   3   4   7 
Current Social Phobia (SAD) - No   190   191   381 
[1] Current (past month) social phobia (SAD) status was assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview that assesses psychiatric disorders.
Obsessive-Compulsive Disorder (OCD) Status [1] 
[Units: Participants]
     
Current OCD - Yes   1   2   3 
Current OCD - No   192   193   385 
[1] Current (past month) OCD status was assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview that assesses psychiatric disorders.
Conners' Adult Attention-Deficit Hyperactivity/Disorder Rating Scale-Investigator Rated: Screening V [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 33.2  (7.7)   33.9  (7.5)   33.6  (7.6) 
[1] 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
  Show All Outcome Measures

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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