Trial · NCT00700427

A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00700427, Phase 3, Completed, Eli Lilly and Company; results first posted 2013-05-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT00700427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00700427

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Trial

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

Title: A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT number: NCT00700427
Status: Completed
Phases: Phase 3
Enrollment: 2,017 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Attention Deficit Hyperactivity Disorder
Interventions: atomoxetine hydrochloride, Placebo
First posted: 2008-06-18
Last updated: 2014-06-26
Results first posted: 2013-05-29

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period	Baseline (Week 24) up to Week 49	Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.
Secondary	Number of Days Until Relapse	Baseline (Week 24) up to Week 49	Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed. CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Secondary	Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49	Baseline (Week 24), Week 49	The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.
Secondary	Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49	Baseline (Week 24), Week 49	The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed 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). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
Secondary	Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49	Baseline (Week 24), Week 49	CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
Secondary	Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49	Baseline (Week 24), Week 49	The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
Secondary	Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49	Baseline (Week 24), Week 49	BRIEF-A:Informant is a 75-item third-party observer's view of the participants' executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
Secondary	Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49	Baseline (Week 24), Week 49	The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with \<0 interpreted as a health state "worse than dead." A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period	Baseline (Week 24) up to Week 49	Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).	percentage of responders	NUMBER
SECONDARY	Number of Days Until Relapse	Baseline (Week 24) up to Week 49	Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).	days	MEAN
SECONDARY	Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49	Baseline (Week 24), Week 49	All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49	Baseline (Week 24), Week 49	Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49	Baseline (Week 24), Week 49	Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).	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) Global Executive Composite (GEC) Index Score From Week 24 to Week 49	Baseline (Week 24), Week 49	Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) 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:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49	Baseline (Week 24), Week 49	Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49	Baseline (Week 24), Week 49	Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period	Atomoxetine		64.3		percentage of responders
Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period	Placebo		50.0		percentage of responders
Number of Days Until Relapse	Atomoxetine		NA	Standard Deviation NA	days
Number of Days Until Relapse	Placebo		NA	Standard Deviation NA	days
Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49	Atomoxetine		0.4	Standard Error 1.12	units on a scale
Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49	Placebo		-4.0	Standard Error 1.10	units on a scale
Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49	Atomoxetine	ADHD Imputed (Attributed) Index Score (N=164, 153)	-2.60	Standard Error 0.56	units on a scale
Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49	Placebo	ADHD Imputed (Attributed) Index Score (N=164, 153)	-0.10	Standard Error 0.57	units on a scale
Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49	Atomoxetine	Hyperactivity/Impulsivity Subscale Imputed Score	-1.90	Standard Error 0.44	units on a scale
Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49	Placebo	Hyperactivity/Impulsivity Subscale Imputed Score	-0.10	Standard Error 0.44	units on a scale

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow65

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

Period	Milestone	Group	Participants
Study Period 2 (Open-Label Acute Trx)	STARTED	Atomoxetine (Study Period 2)	2,017
Study Period 2 (Open-Label Acute Trx)	STARTED	Atomoxetine (Study Period 3A)	0
Study Period 2 (Open-Label Acute Trx)	STARTED	Atomoxetine (Study Period 3B)	0
Study Period 2 (Open-Label Acute Trx)	STARTED	Placebo (Study Period 3B)	0
Study Period 2 (Open-Label Acute Trx)	STARTED	Atomoxetine (Study Period 4)	0
Study Period 2 (Open-Label Acute Trx)	Received at Least One Dose of Study Drug	Atomoxetine (Study Period 2)	2,011
Study Period 2 (Open-Label Acute Trx)	Received at Least One Dose of Study Drug	Atomoxetine (Study Period 3A)	0
Study Period 2 (Open-Label Acute Trx)	Received at Least One Dose of Study Drug	Atomoxetine (Study Period 3B)	0
Study Period 2 (Open-Label Acute Trx)	Received at Least One Dose of Study Drug	Placebo (Study Period 3B)	0
Study Period 2 (Open-Label Acute Trx)	Received at Least One Dose of Study Drug	Atomoxetine (Study Period 4)	0

1 to 10 of 65Source ClinicalTrials.gov

See all 65 participant flow

Adverse events520

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	Angina pectoris	Cardiac disorders	Atomoxetine (Study Periods 2 and 3A)	2	2,011	2
other	Angina pectoris	Cardiac disorders	Atomoxetine (Study Period 3B)	2	266	2
other	Angina pectoris	Cardiac disorders	Placebo (Study Period 3B)	0	258	0
other	Angina pectoris	Cardiac disorders	Atomoxetine (Study Period 4; Open-Label Extension)	3	180	3
other	Palpitations	Cardiac disorders	Atomoxetine (Study Periods 2 and 3A)	83	2,011	90
other	Palpitations	Cardiac disorders	Atomoxetine (Study Period 3B)	1	266	1
other	Palpitations	Cardiac disorders	Placebo (Study Period 3B)	1	258	1
other	Palpitations	Cardiac disorders	Atomoxetine (Study Period 4; Open-Label Extension)	2	180	2
other	Tachycardia	Cardiac disorders	Atomoxetine (Study Periods 2 and 3A)	70	2,011	73
other	Tachycardia	Cardiac disorders	Atomoxetine (Study Period 3B)	3	266	4

1 to 10 of 520Source ClinicalTrials.gov

See all 520 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atomoxetine (Study Periods 2 and 3A)
Total, all-cause mortality	Atomoxetine (Study Period 3B)
Total, all-cause mortality	Placebo (Study Period 3B)
Total, all-cause mortality	Atomoxetine (Study Period 4; Open-Label Extension)
Total, other adverse events	Atomoxetine (Study Periods 2 and 3A)	1,611	2,011
Total, other adverse events	Atomoxetine (Study Period 3B)	120	266
Total, other adverse events	Placebo (Study Period 3B)	96	258
Total, other adverse events	Atomoxetine (Study Period 4; Open-Label Extension)	119	180
Total, serious adverse events	Atomoxetine (Study Periods 2 and 3A)	29	2,011
Total, serious adverse events	Atomoxetine (Study Period 3B)	7	266

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23648011	DERIVED	PubMed
26329980	DERIVED	PubMed
28058589	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 comparisons0

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

None in this release.

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.

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