Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT00636818, Phase 2, Completed, Eli Lilly and Company; results first posted 2009-12-23
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD) | ClinicalTrials.gov |
| NCT number | NCT00636818 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 45 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Eli Lilly and Company | ClinicalTrials.gov |
| Conditions | Attention Deficit Hyperactivity Disorder | ClinicalTrials.gov |
| Interventions | Atomoxetine | ClinicalTrials.gov |
| First posted | 2008-03-14 | ClinicalTrials.gov |
| Last updated | 2010-11-04 | ClinicalTrials.gov |
| Results first posted | 2009-12-23 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Discontinuations Due to Adverse Events (AE) | Baseline to 8 Weeks | The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation. | ClinicalTrials.gov |
| Secondary | Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score | Baseline and 8 Weeks | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S) | Baseline and 8 Weeks | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | ClinicalTrials.gov |
| Secondary | Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score | Baseline and 8 Weeks | Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) | Baseline and 8 Weeks | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). | ClinicalTrials.gov |
| Secondary | Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14) | Baseline and 8 Weeks | The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. | ClinicalTrials.gov |
| Secondary | Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Baseline and 8 Weeks | This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. | ClinicalTrials.gov |
| Secondary | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Baseline and 8 Weeks | SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score\*10+50 in each subscale. Range cannot be specified in norm-based scores. | ClinicalTrials.gov |
| Secondary | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Baseline to 8 Weeks | Vital signs reported are Pulse (beats per minute \[bpm\]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg). | ClinicalTrials.gov |
| Secondary | Significant Changes in Body Weight During the Study | Baseline to 8 Weeks | Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%. | ClinicalTrials.gov |
| Secondary | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | Baseline to 8 Weeks | The Fridericia correction of the QT interval (QTcF) was used. | ClinicalTrials.gov |
| Secondary | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | 8 Weeks | CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer. | ClinicalTrials.gov |
Outcomes 12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Discontinuations Due to Adverse Events (AE) | Baseline to 8 Weeks | Number of participants who received at least one dose of study drug. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score | Baseline and 8 Weeks | Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S) | Baseline and 8 Weeks | Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score | Baseline and 8 Weeks | Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) | Baseline and 8 Weeks | Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14) | Baseline and 8 Weeks | Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Baseline and 8 Weeks | Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward. | number of correct answers | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Baseline and 8 Weeks | Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward. | T-Score | MEAN | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Baseline to 8 Weeks | Number of participants with baseline and post-baseline values. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Significant Changes in Body Weight During the Study | Baseline to 8 Weeks | Number of participants with baseline and post-baseline values. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | Baseline to 8 Weeks | Number of participants with baseline and post-baseline values. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | 8 Weeks | Number of participants who received at least one dose of study drug. | participants | NUMBER | ClinicalTrials.gov |
Results by group 53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Discontinuations Due to Adverse Events (AE) | Atomoxetine | Participants with >=1 AE (Discontinuation) | 1 | participants | ClinicalTrials.gov | |
| Discontinuations Due to Adverse Events (AE) | Atomoxetine | Somnolence (Nervous System Disorder) | 1 | participants | ClinicalTrials.gov | |
| Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score | Atomoxetine | Baseline | 32.0 | Standard Deviation 6.3 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score | Atomoxetine | Change from Baseline | -12.8 | Standard Deviation 10.4 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S) | Atomoxetine | Baseline | 4.8 | Standard Deviation 0.8 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S) | Atomoxetine | Change from Baseline | -1.7 | Standard Deviation 1.3 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score | Atomoxetine | Baseline | 30.6 | Standard Deviation 9.7 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score | Atomoxetine | Change from Baseline | -12.1 | Standard Deviation 10.2 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) | Atomoxetine | Baseline | 4.8 | Standard Deviation 3.9 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) | Atomoxetine | Change from Baseline | -1.5 | Standard Deviation 3.8 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14) | Atomoxetine | Baseline | 6.7 | Standard Deviation 4.7 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14) | Atomoxetine | Change from Baseline | -2.0 | Standard Deviation 4.4 | units on a scale | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Atomoxetine | Word Test: Baseline | 82.4 | Standard Deviation 16.6 | number of correct answers | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Atomoxetine | Word Test: Change from Baseline | 4.5 | Standard Deviation 9.9 | number of correct answers | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Atomoxetine | Color Test: Baseline | 68.7 | Standard Deviation 14.8 | number of correct answers | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Atomoxetine | Color Test: Change from Baseline | 4.8 | Standard Deviation 10.6 | number of correct answers | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Atomoxetine | Color-Word Test: Baseline | 49.0 | Standard Deviation 16.5 | number of correct answers | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Stroop Color Word Test | Atomoxetine | Color-Word Test: Change from Baseline | 3.5 | Standard Deviation 15.4 | number of correct answers | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Atomoxetine | Physical Component Summary: Baseline | 46.77 | Standard Deviation 9.11 | T-Score | ClinicalTrials.gov |
| Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) | Atomoxetine | Physical Component Summary: Change from Baseline | -0.38 | Standard Deviation 9.23 | T-Score | ClinicalTrials.gov |
Participant flow 4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Atomoxetine | 45 | ClinicalTrials.gov | |
| Overall Study | Received at Least One Dose of Study Drug | Atomoxetine | 44 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Atomoxetine | 34 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Atomoxetine | 11 | ClinicalTrials.gov |
Adverse events 15
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 | Source |
|---|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Atomoxetine | 5 | 44 | 6 | ClinicalTrials.gov |
| other | Dry mouth | Gastrointestinal disorders | Atomoxetine | 5 | 44 | 5 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 16 | 44 | 19 | ClinicalTrials.gov |
| other | Vomiting | Gastrointestinal disorders | Atomoxetine | 4 | 44 | 5 | ClinicalTrials.gov |
| other | Asthenia | General disorders | Atomoxetine | 4 | 44 | 4 | ClinicalTrials.gov |
| other | Fatigue | General disorders | Atomoxetine | 6 | 44 | 6 | ClinicalTrials.gov |
| other | Irritability | General disorders | Atomoxetine | 3 | 44 | 3 | ClinicalTrials.gov |
| other | Anorexia | Metabolism and nutrition disorders | Atomoxetine | 3 | 44 | 3 | ClinicalTrials.gov |
| other | Decreased appetite | Metabolism and nutrition disorders | Atomoxetine | 7 | 44 | 8 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | Atomoxetine | 15 | 44 | 19 | ClinicalTrials.gov |
| other | Headache | Nervous system disorders | Atomoxetine | 5 | 44 | 5 | ClinicalTrials.gov |
| other | Somnolence | Nervous system disorders | Atomoxetine | 13 | 44 | 13 | ClinicalTrials.gov |
| other | Insomnia | Psychiatric disorders | Atomoxetine | 7 | 44 | 7 | ClinicalTrials.gov |
| other | Hyperhidrosis | Skin and subcutaneous tissue disorders | Atomoxetine | 3 | 44 | 3 | ClinicalTrials.gov |
| serious | Hand-foot-and-mouth disease | Infections and infestations | Atomoxetine | 1 | 44 | 1 | ClinicalTrials.gov |
Adverse event totals 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Atomoxetine | ClinicalTrials.gov | ||
| Total, other adverse events | Atomoxetine | 41 | 44 | ClinicalTrials.gov |
| Total, serious adverse events | Atomoxetine | 1 | 44 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)