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

History of Changes

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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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

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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 ]

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

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 ]

Show Outcome Measure 3

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 ]

Show Outcome Measure 4

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 ]

Show Outcome Measure 5

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 ]

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

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 ]

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

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 ]

Show Outcome Measure 14

15. Secondary:

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

Show Outcome Measure 15

16. Secondary:

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

Show Outcome Measure 16

17. Secondary:

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

Show Outcome Measure 17

18. Secondary:

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

Show Outcome Measure 18

19. Secondary:

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

Show Outcome Measure 19

20. Secondary:

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

Show Outcome Measure 20

21. Secondary:

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

Show Outcome Measure 21

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 ]

Show Outcome Measure 22

23. Secondary:

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

Show Outcome Measure 23

24. Secondary:

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

Show Outcome Measure 24

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 ]

Show Outcome Measure 25

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 ]

Show Outcome Measure 26

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 ]

Show Outcome Measure 27

28. Secondary:

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

Show Outcome Measure 28

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 ]

Show Outcome Measure 29

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 ]

Show Outcome Measure 30

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 ]

Show Outcome Measure 31

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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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 of Results:

Young JL, Sarkis E, Qiao M, Wietecha L. Once-daily treatment with atomoxetine in adults with attention-deficit/hyperactivity disorder: a 24-week, randomized, double-blind, placebo-controlled trial. Clin Neuropharmacol. 2011 Mar-Apr;34(2):51-60.

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

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