A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190775
First received: September 12, 2005
Last updated: August 18, 2011
Last verified: October 2010
Results First Received: July 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: Atomoxetine Hydrochloride
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 Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally

Participant Flow:   Overall Study
    Atomoxetine     Placebo  
STARTED     268     234  
Received Study Drug     266     234  
COMPLETED     119     134  
NOT COMPLETED     149     100  
Adverse Event                 57                 22  
Satisfactory Response                 1                 0  
Lack of Efficacy                 28                 32  
Lost to Follow-up                 31                 23  
Participant Moved                 0                 1  
Withdrawal by Subject                 24                 13  
Sponsor Decision                 1                 0  
Physician Decision                 3                 0  
Noncompliance                 3                 5  
Protocol Violation                 0                 1  
Exclusion Criteria Met                 1                 3  



  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.
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Reporting Groups
  Description
Atomoxetine Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Total Total of all reporting groups

Baseline Measures
    Atomoxetine     Placebo     Total  
Number of Participants  
[units: participants]
  268     234     502  
Age  
[units: Years]
Mean ± Standard Deviation
  41.21  ± 6.89     41.39  ± 7.49     41.30  ± 7.17  
Gender  
[units: Participants]
     
Female     131     132     263  
Male     137     102     239  
Race/Ethnicity, Customized  
[units: Participants]
     
Hispanic     24     20     44  
Caucasian     227     199     426  
African Descent     11     6     17  
East/Southeast Asian     0     2     2  
Western Asian     1     0     1  
Other     5     7     12  
Region of Enrollment  
[units: Participants]
     
United States     255     224     479  
Puerto Rico     13     10     23  
Attention Deficit Hyperactivity Disorder (ADHD) Subtype  
[units: Participants]
     
Combined     179     166     345  
Inattentive     89     67     156  
Hyperactive/Impulsive     0     1     1  
Previous Stimulant Exposure  
[units: Participants]
     
Yes     47     35     82  
No     220     198     418  
Unknown or Not Reported     1     1     2  
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) [1]
[units: Units on a scale]
Mean ± Standard Deviation
     
AISRS Total Score     36.07  ± 7.64     36.59  ± 8.34     36.31  ± 7.97  
AISRS Inattention Score     20.91  ± 3.83     20.62  ± 4.02     20.77  ± 3.92  
AISRS Hyperactivity Score     15.16  ± 5.75     15.97  ± 5.94     15.54  ± 5.85  
Alabama Parenting Questionnaire (APQ) [2]
[units: Units on a scale]
Mean ± Standard Deviation
     
Child Involvement Mother     35.30  ± 6.02     36.09  ± 5.90     35.67  ± 5.97  
Child Involvement Father     31.50  ± 6.85     32.35  ± 6.86     31.90  ± 6.86  
Child Positive Parenting     23.85  ± 4.04     23.40  ± 4.02     23.64  ± 4.03  
Child Poor Monitoring/Supervision     16.93  ± 4.92     17.27  ± 5.34     17.09  ± 5.12  
Child Inconsistent Discipline     12.66  ± 3.44     13.01  ± 3.57     12.83  ± 3.50  
Child Corporal Punishment     4.86  ± 2.08     4.99  ± 2.37     4.92  ± 2.22  
Child Other Discipline Practice     17.62  ± 3.52     18.18  ± 3.88     17.88  ± 3.70  
Parent Involvement     37.71  ± 5.11     37.61  ± 5.62     37.67  ± 5.34  
Parent Positive Parenting     24.53  ± 3.26     24.06  ± 3.58     24.31  ± 3.42  
Parent Poor Monitoring Supervision     16.64  ± 4.91     16.50  ± 4.78     16.58  ± 4.85  
Parent Inconsistent Discipline     15.37  ± 3.44     15.48  ± 3.42     15.42  ± 3.42  
Parent Corporal Punishment     4.73  ± 1.60     4.75  ± 1.76     4.74  ± 1.67  
Parent Other Discipline Practice     19.53  ± 3.08     19.64  ± 2.96     19.58  ± 3.02  
Parent Dysfunctional Parenting Composite     0.12  ± 0.98     0.17  ± 1.01     0.14  ± 0.99  
Parent Negative Parenting     0.21  ± 1.05     0.21  ± 0.99     0.21  ± 1.02  
Parent Positive Parenting     -0.00  ± 0.95     -0.07  ± 1.05     -0.04  ± 1.00  
Body Mass Index (BMI) [3]
[units: Kilograms/square meters]
Mean ± Standard Deviation
  30.15  ± 6.58     29.31  ± 6.51     29.76  ± 6.56  
Child Disruptive Behavior Rating Scale (CDBRS) Parent Form [4]
[units: Units on a scale]
Mean ± Standard Deviation
     
Total Score     24.56  ± 13.30     24.35  ± 13.01     24.46  ± 13.16  
Inattention Symptom ADHD Score     13.39  ± 7.30     13.35  ± 6.86     13.37  ± 7.09  
Hyperactive-Impulsive Symptom ADHD Score     11.17  ± 6.98     11.00  ± 6.95     11.09  ± 6.96  
Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) [5]
[units: Units on a scale]
Mean ± Standard Deviation
  4.56  ± 0.62     4.58  ± 0.60     4.57  ± 0.61  
Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV) [6]
[units: Units on a scale]
Mean ± Standard Deviation
     
Total ADHD Symptoms Score     34.64  ± 8.39     35.50  ± 8.53     35.04  ± 8.46  
Inattention Subscale     19.97  ± 4.45     19.90  ± 4.33     19.94  ± 4.39  
Hyper/Impulsive Subscale     14.67  ± 5.89     15.60  ± 5.80     15.11  ± 5.86  
Index Subscale     21.60  ± 5.37     21.49  ± 5.74     21.55  ± 5.54  
Dyadic Adjustment Scale (DAS) - Participant (Self) [7]
[units: T-scores of units on a scale]
Mean ± Standard Deviation
     
Total Dyadic Adjustment     43.06  ± 11.90     42.37  ± 11.11     42.74  ± 11.53  
Affectional Expression     43.70  ± 12.52     44.85  ± 11.68     44.24  ± 12.14  
Dyadic Cohesion     52.51  ± 10.63     51.58  ± 10.02     52.08  ± 10.35  
Dyadic Consensus     44.99  ± 9.22     44.26  ± 8.69     44.65  ± 8.98  
Dyadic Satisfaction     42.98  ± 10.82     42.49  ± 10.24     42.75  ± 10.55  
Dyadic Adjustment Scale (DAS) - Spouse/Significant Other [8]
[units: T-scores of units on a scale]
Mean ± Standard Deviation
     
Total Dyadic Adjustment     41.93  ± 11.44     41.75  ± 11.29     41.85  ± 11.36  
Affectational Expression     43.18  ± 11.97     43.66  ± 12.28     43.41  ± 12.10  
Dyadic Cohesion     51.35  ± 11.09     51.70  ± 10.30     51.51  ± 10.72  
Dyadic Consensus     40.82  ± 10.18     40.44  ± 10.02     40.64  ± 10.10  
Dyadic Satisfaction     42.25  ± 10.75     41.84  ± 10.53     42.06  ± 10.64  
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) [9]
[units: T-scores of units on a scale]
Mean ± Standard Deviation
     
Task Accomplishment     62.78  ± 5.56     62.38  ± 5.43     62.59  ± 5.50  
Role Performance     60.81  ± 5.03     61.13  ± 5.75     60.96  ± 5.37  
Communication     64.97  ± 6.49     64.24  ± 6.35     64.63  ± 6.43  
Affective Expression     61.48  ± 8.63     61.71  ± 9.47     61.59  ± 9.02  
Involvement     64.07  ± 7.92     64.59  ± 7.35     64.31  ± 7.66  
Control     62.70  ± 5.95     62.13  ± 6.07     62.43  ± 6.01  
Values and Norms     65.66  ± 6.70     64.90  ± 7.44     65.30  ± 7.06  
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other [10]
[units: T-scores of units on a scale]
Mean ± Standard Deviation
     
Task Accomplishment     61.52  ± 5.97     60.90  ± 5.83     61.23  ± 5.91  
Role Performance     61.28  ± 5.67     60.59  ± 6.00     60.96  ± 5.83  
Communication     64.05  ± 6.37     63.47  ± 7.02     63.78  ± 6.68  
Affective Expression     61.97  ± 9.67     61.68  ± 9.07     61.84  ± 9.39  
Involvement     64.96  ± 8.95     64.52  ± 8.77     64.76  ± 8.86  
Control     61.98  ± 6.52     61.34  ± 6.25     61.68  ± 6.40  
Values and Norms     65.32  ± 7.11     65.52  ± 7.17     65.41  ± 7.13  
Height  
[units: Centimeters]
Mean ± Standard Deviation
  171.23  ± 10.37     170.01  ± 9.74     170.66  ± 10.09  
Montgomery-Asberg Depression Rating Scale Total Score (MADRS) [11]
[units: Units on a scale]
Mean ± Standard Deviation
  8.13  ± 4.80     8.12  ± 5.01     8.13  ± 4.89  
Parent Stress Index (PSI) Total Stress and Life Stress [12]
[units: Units on a scale]
Mean ± Standard Deviation
     
Total Stress     285.40  ± 53.45     277.11  ± 52.65     281.53  ± 53.18  
Life Stress     1.57  ± 3.56     1.76  ± 3.68     1.66  ± 3.62  
Parent Stress Index (PSI) Parent Domains [13]
[units: Units on a scale]
Mean ± Standard Deviation
     
Parent Domain Total     135.40  ± 25.22     130.22  ± 24.62     132.98  ± 25.05  
Parent Domain Role Restriction     18.93  ± 5.33     18.26  ± 4.99     18.62  ± 5.18  
Parent Domain Depression     22.79  ± 6.10     21.01  ± 5.68     21.96  ± 5.97  
Parent Domain Spouse     18.19  ± 5.03     18.14  ± 5.04     18.17  ± 5.03  
Parent Domain Competence     32.63  ± 6.69     31.78  ± 7.10     32.23  ± 6.89  
Parent Domain Isolation     15.49  ± 4.71     14.56  ± 4.61     15.06  ± 4.68  
Parent Domain Attachment     13.74  ± 4.21     12.95  ± 3.61     13.37  ± 3.96  
Parent Domain Health     13.72  ± 2.71     13.52  ± 2.62     13.63  ± 2.67  
Parent Stress Index (PSI) Child Domains [14]
[units: Units on a scale]
Mean ± Standard Deviation
     
Child Domain Total     150.00  ± 34.46     146.88  ± 34.44     148.54  ± 34.45  
Child Domain Distractibility/Hyperactivity     27.49  ± 6.46     27.59  ± 6.48     27.54  ± 6.47  
Child Domain Adaptability     48.29  ± 11.56     47.59  ± 12.28     47.96  ± 11.89  
Child Domain Reinforces Parent     24.87  ± 7.13     23.75  ± 7.07     24.34  ± 7.12  
Child Domain Demandingness     20.99  ± 6.09     20.71  ± 6.48     20.85  ± 6.27  
Child Domain Mood     12.42  ± 3.89     12.06  ± 4.03     12.25  ± 3.96  
Child Domain Acceptability     15.94  ± 4.75     15.18  ± 4.67     15.59  ± 4.72  
Parenting Sense of Competence (PSOC) Scale [15]
[units: Units on a scale]
Mean ± Standard Deviation
     
Total     58.64  ± 9.83     60.80  ± 9.18     59.65  ± 9.58  
Satisfaction Scale     33.46  ± 6.58     34.94  ± 6.38     34.15  ± 6.52  
Efficacy Scale     25.18  ± 4.72     25.86  ± 4.31     25.50  ± 4.54  
State-Trait Anxiety Inventories (STAI) [16]
[units: Units on a scale]
Mean ± Standard Deviation
     
State Anxiety Score     40.13  ± 11.55     41.16  ± 11.18     40.61  ± 11.38  
Trait Anxiety Score     47.44  ± 10.68     46.05  ± 11.22     46.79  ± 10.94  
Weight  
[units: Kilograms]
Mean ± Standard Deviation
  88.22  ± 20.40     84.84  ± 19.72     86.65  ± 20.14  
[1] 18-item scale that captures the 18-item Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) symptoms of ADHD. 9 inattentive items alternate with 9 hyperactive/impulsive items. Each item is scored 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The total score range is 0-54 (0-27 for each subscale). Higher scores indicate more impaired participants. The scale was administered by a physician or PhD at the investigative site.
[2] 42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.
[3] Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.
[4] Child Disruptive Behavior Rating Scale (CDBRS) contains the symptoms of ADHD (9 items for Inattention/9 items for Hyperactive-Impulsive). Total maximum severity score is 54 (0-27 for each subscore). Higher scores indicate greater impairment. Participants with a child aged 6-12 or 13-17 years old living in the home completed the scale.
[5] The CGI-ADHD-S is a single-item rating of the clinician’s assessment of the severity of ADHD symptoms in relation to the clinician’s total experience with ADHD subjects. Severity is rated on a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill subjects). The scale was administered by a physician or PhD at the investigative site.
[6] 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
[7] 32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, standard deviation (SD)=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
[8] 32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
[9] FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.
[10] FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.
[11] The MADRS is an investigator administered rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
[12] The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
[13] 120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
[14] 120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
[15] 16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
[16] Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant reports how they feel “right now at this moment” for state anxiety and how they “generally” feel for trait anxiety. The “state” items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The “trait” items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 4-80 for each scale. Higher scores indicate more impaired participants.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score   [ Time Frame: Baseline, 24 weeks ]

2.  Primary:   Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score   [ Time Frame: Baseline, 12 weeks ]

3.  Secondary:   Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant   [ Time Frame: Baseline, 8 weeks ]

4.  Secondary:   Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant   [ Time Frame: Baseline, 24 weeks ]

5.  Secondary:   Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other   [ Time Frame: Baseline, 8 weeks ]

6.  Secondary:   Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other   [ Time Frame: Baseline, 24 weeks ]

7.  Secondary:   Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant   [ Time Frame: Baseline, 8 weeks ]

8.  Secondary:   Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant   [ Time Frame: Baseline, 24 weeks ]

9.  Secondary:   Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other   [ Time Frame: Baseline, 8 weeks ]

10.  Secondary:   Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other   [ Time Frame: Baseline, 24 weeks ]

11.  Secondary:   Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress   [ Time Frame: Baseline, 8 weeks ]

12.  Secondary:   Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains   [ Time Frame: Baseline, 8 weeks ]

13.  Secondary:   Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains   [ Time Frame: Baseline, 8 weeks ]

14.  Secondary:   Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress   [ Time Frame: Baseline, 24 weeks ]

15.  Secondary:   Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains   [ Time Frame: Baseline, 24 weeks ]

16.  Secondary:   Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains   [ Time Frame: Baseline, 24 weeks ]

17.  Secondary:   Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form   [ Time Frame: Baseline, 12 weeks ]

18.  Secondary:   Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form   [ Time Frame: Baseline, 24 weeks ]

19.  Secondary:   Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form   [ Time Frame: Baseline, 12 Weeks ]

20.  Secondary:   Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form   [ Time Frame: Baseline, 24 Weeks ]

21.  Secondary:   Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form   [ Time Frame: Baseline, 24 weeks ]

22.  Secondary:   Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags   [ Time Frame: Baseline, 24 weeks ]

23.  Secondary:   Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale   [ Time Frame: Baseline, 8 weeks ]

24.  Secondary:   Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale   [ Time Frame: Baseline, 24 weeks ]

25.  Secondary:   Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

26.  Secondary:   Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)   [ Time Frame: Baseline, 8 weeks, 24 weeks ]

27.  Secondary:   Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)   [ Time Frame: Baseline 12 weeks, 24 weeks ]

28.  Secondary:   Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

29.  Secondary:   Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores   [ Time Frame: Baseline, 1 week ]

30.  Secondary:   Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores   [ Time Frame: Baseline, 2 weeks ]

31.  Secondary:   Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo   [ Time Frame: Baseline, after 2-week titration period beginning at Week 24 ]


  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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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 of Results:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00190775     History of Changes
Other Study ID Numbers: 9043, B4Z-US-LYCW
Study First Received: September 12, 2005
Results First Received: July 14, 2010
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration