Trial · NCT00962104

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

NCT00962104, Phase 3, Completed, Eli Lilly and Company; results first posted 2012-09-11

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder. Trials, record NCT00962104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00962104

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder
NCT number: NCT00962104
Status: Completed
Phases: Phase 3
Enrollment: 391 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Attention Deficit Hyperactivity Disorder
Interventions: Atomoxetine, Placebo
First posted: 2009-08-19
Last updated: 2012-09-11
Results first posted: 2012-09-11

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	Baseline, up to 10 weeks	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.
Secondary	Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks	Baseline, up to 10 weeks	Participant-reported outcome measure used to examine disease-specific functional impairments and QoL for adults with ADHD. The domains include work functioning, family relationships, social functioning, activities of daily living (that is, driving, managing finances), and psychological adaptation (that is, life satisfaction and self-esteem). Individual items scored on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). Range of scores for this subscale is 0 to 100. Consistent with the majority of existing QoL measures, higher scores on AAQoL-29 indicate better functioning.
Secondary	Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks	Baseline, up to 10 weeks	The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state.
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	10 weeks	CAARS-Inv:SV assesses symptom severity over past week. Total ADHD symptom score comprises 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). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment\*visit. Baseline included as a covariate; thus, treatment difference in observed value is same as change from baseline.
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	10 weeks	Participant assessment of symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention \[9 items, range: 0-27\] and hyperactivity-impulsivity \[9 items, range: 0-27\] subscales) using 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment\*visit. Baseline included as covariate; thus, treatment difference in observed value is same as change from baseline.
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	Baseline, up to 10 weeks	A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75- 225 total score). Higher subscale ratings=greater perceived impairment.
Secondary	Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks	Baseline, up to 10 weeks	Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75-225 total score). Higher subscale ratings=greater perceived impairment.
Secondary	Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks	Baseline, up to 10 weeks	The CGI-ADHD-S is a single-item clinician rating of the clinician's assessment of the overall severity of the participant's ADHD symptoms in relation to the clinician's total experience with ADHD participants. Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill to 7=among the most extremely ill participants).
Secondary	Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks	Up to 10 weeks	The CGI-ADHD-I is a single-item clinician rating of the clinician's assessment of the participant's improvement in ADHD symptoms in relation to the clinician's total experience with ADHD participants. Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment (1=very much improved to 7=very much worsened).
Secondary	Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks	Baseline, up to 10 weeks	Clinician-administered rating scale that assesses severity of anxiety and its improvement (or change) during course of treatment (Hamilton 1959; Riskind et al. 1987). Scale consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. Investigator talked to participant about participant's symptoms over previous week before study visit. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score=sum of 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate a greater degree of symptom severity.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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	Baseline, up to 10 weeks	All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result within each treatment group, last observation carried forward (LOCF) were included in the analysis.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks	Baseline, up to 10 weeks	All randomized participants with a baseline and at least 1 post-baseline AAQoL result within each treatment group, last observation carried forward (LOCF) were included in the analysis.	units on a scale	MEAN
SECONDARY	Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks	Baseline, up to 10 weeks	All randomized participants with a baseline and at least 1 post-baseline EQ-5D result within each treatment group, last observation carried forward (LOCF) were included in the analysis.	units on a scale	MEAN
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	10 weeks	All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result were included in the analysis.	units on a scale	LEAST_SQUARES_MEAN
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	10 weeks	All randomized participants with a baseline and at least 1 post-baseline CAARS-S:SV result were included in the analysis.	units on a scale	LEAST_SQUARES_MEAN
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	Baseline, up to 10 weeks	All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks	Baseline, up to 10 weeks	All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks	Baseline, up to 10 weeks	All randomized participants with a baseline and at least 1 post-baseline CGI-ADHD-S result within each treatment group, last observation carried forward (LOCF) were included in the analysis.	units on a scale	MEAN
SECONDARY	Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks	Up to 10 weeks	All randomized participants with an endpoint CGI-ADHD-I value within each treatment group, last observation carried forward (LOCF) were included in the analysis.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks	Baseline, up to 10 weeks	All randomized participants with a baseline and at least 1 post-baseline HAMA-14 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.	units on a scale	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
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	Atomoxetine	-14.3	Standard Deviation 10.4	units on a scale
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	Placebo	-8.8	Standard Deviation 9.6	units on a scale
Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks	Atomoxetine	12.83	Standard Deviation 15.91	units on a scale
Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks	Placebo	8.20	Standard Deviation 14.09	units on a scale
Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks	Atomoxetine	1.4	Standard Deviation 20.3	units on a scale
Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks	Placebo	1.5	Standard Deviation 18.4	units on a scale
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	Atomoxetine	17.24	Standard Error 0.74	units on a scale
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	Placebo	23.42	Standard Error 0.73	units on a scale
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	Atomoxetine	16.80	Standard Error 0.77	units on a scale
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	Placebo	22.97	Standard Error 0.75	units on a scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Atomoxetine	195
Overall Study	STARTED	Placebo	196
Overall Study	Full Analysis Set	Atomoxetine	193
Overall Study	Full Analysis Set	Placebo	195
Overall Study	COMPLETED	Atomoxetine	155
Overall Study	COMPLETED	Placebo	171
Overall Study	NOT COMPLETED	Atomoxetine	40
Overall Study	NOT COMPLETED	Placebo	25

Source ClinicalTrials.gov

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Atomoxetine	17	193	17
other	Constipation	Gastrointestinal disorders	Placebo	9	195	9
other	Dry mouth	Gastrointestinal disorders	Atomoxetine	21	193	21
other	Dry mouth	Gastrointestinal disorders	Placebo	5	195	6
other	Nausea	Gastrointestinal disorders	Atomoxetine	81	193	100
other	Nausea	Gastrointestinal disorders	Placebo	10	195	11
other	Vomiting	Gastrointestinal disorders	Atomoxetine	13	193	16
other	Vomiting	Gastrointestinal disorders	Placebo	2	195	2
other	Fatigue	General disorders	Atomoxetine	10	193	10
other	Fatigue	General disorders	Placebo	9	195	9

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atomoxetine
Total, all-cause mortality	Placebo
Total, other adverse events	Atomoxetine	156	193
Total, other adverse events	Placebo	104	195
Total, serious adverse events	Atomoxetine	1	193
Total, serious adverse events	Placebo	2	195

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
3625186	BACKGROUND	PubMed
13638508	BACKGROUND	PubMed
25019647	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Atomoxetine vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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