Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
NCT00530335, Phase 2, Completed, Eli Lilly and Company; results first posted 2009-06-10
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD) | ClinicalTrials.gov |
| NCT number | NCT00530335 | 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 | 2007-09-17 | ClinicalTrials.gov |
| Last updated | 2011-07-27 | ClinicalTrials.gov |
| Results first posted | 2009-06-10 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events Leading to Discontinuation | over 8 weeks | ClinicalTrials.gov | |
| Secondary | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | baseline and 8 weeks | Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54. | ClinicalTrials.gov |
| Secondary | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | baseline and 8 weeks | Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54. | ClinicalTrials.gov |
| Secondary | Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity | 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 Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score | 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 Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score | baseline and 8 weeks | The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe). | ClinicalTrials.gov |
| Secondary | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | baseline and 8 weeks | Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales. Calculate: norm-based score=Z-score\*10+50 in each subscale. | ClinicalTrials.gov |
| Secondary | Change From Endpoint to Baseline in Stroop Color Word Test | baseline and 8 weeks | An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list. | ClinicalTrials.gov |
| Secondary | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | over 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 | Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study | over 8 weeks | Potentially clinically significant weight loss was defined as any decrease of at least 7%. 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 | over 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. Metabolizer 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 | Number of Participants With Adverse Events Leading to Discontinuation | over 8 weeks | All three participants who discontinued due to an adverse event were on atomoxetine doses of between 80 mg/day and 105 mg/day. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | baseline and 8 weeks | All enrolled participants with Last Observation Carried Forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | baseline and 8 weeks | All enrolled participants with Last Observation Carried Forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity | baseline and 8 weeks | All enrolled participants with Last Observation Carried Forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score | baseline and 8 weeks | All enrolled participants with Last Observation Carried Forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score | baseline and 8 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | baseline and 8 weeks | All enrolled participants with Last Observation Carried Forward. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Endpoint to Baseline in Stroop Color Word Test | baseline and 8 weeks | All enrolled participants with Last Observation Carried Forward. | number of correct answers | MEAN | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | over 8 weeks | All enrolled participants. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study | over 8 weeks | All enrolled participants. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | over 8 weeks | All enrolled participants. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | 8 weeks | participants | NUMBER | ClinicalTrials.gov |
Results by group 55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Number of Participants With Adverse Events Leading to Discontinuation | Atomoxetine | Nausea | 1 | participants | ClinicalTrials.gov | |
| Number of Participants With Adverse Events Leading to Discontinuation | Atomoxetine | Malaise | 1 | participants | ClinicalTrials.gov | |
| Number of Participants With Adverse Events Leading to Discontinuation | Atomoxetine | Anorexia | 1 | participants | ClinicalTrials.gov | |
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | Atomoxetine | Total ADHD Symptoms Score | -15.0 | Standard Deviation 9.0 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | Atomoxetine | Inattentive Subscale | -9.9 | Standard Deviation 6.7 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | Atomoxetine | Hyperactivity/Impulsive Subscale | -5.0 | Standard Deviation 4.6 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | Atomoxetine | ADHD Index Subscale | -9.3 | Standard Deviation 6.4 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | Atomoxetine | Total ADHD Symptoms Score | -11.9 | Standard Deviation 10.6 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | Atomoxetine | Inattentive Subscale | -7.0 | Standard Deviation 7.0 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | Atomoxetine | Hyperactive/Impulsive Subscale | -4.9 | Standard Deviation 4.8 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | Atomoxetine | ADHD Index Subscale | -6.4 | Standard Deviation 6.8 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity | Atomoxetine | -1.2 | Standard Deviation 1.2 | units on a scale | ClinicalTrials.gov | |
| Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score | Atomoxetine | 0.2 | Standard Deviation 4.2 | units on a scale | ClinicalTrials.gov | |
| Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score | Atomoxetine | -0.1 | Standard Deviation 6.2 | units on a scale | ClinicalTrials.gov | |
| Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Atomoxetine | Physical Component Summary Baseline | 47.9 | Standard Deviation 9.52 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Atomoxetine | Physical Component Summary Change from Baseline | 1.20 | Standard Deviation 9.64 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Atomoxetine | Mental Component Summary Baseline | 44.46 | Standard Deviation 7.26 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Atomoxetine | Mental Component Summary Change from Baseline | 0.86 | Standard Deviation 6.61 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Atomoxetine | Physical Functioning Baseline | 54.74 | Standard Deviation 5.42 | units on a scale | ClinicalTrials.gov |
| Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Atomoxetine | Physical Functioning Change from Baseline | -0.63 | Standard Deviation 4.94 | units on a scale | ClinicalTrials.gov |
Participant flow 3
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 | COMPLETED | Atomoxetine | 39 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Atomoxetine | 6 | ClinicalTrials.gov |
Adverse events 24
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 | 7 | 45 | 7 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | Atomoxetine | 7 | 45 | 7 | ClinicalTrials.gov |
| other | Dry mouth | Gastrointestinal disorders | Atomoxetine | 4 | 45 | 4 | ClinicalTrials.gov |
| other | Dyspepsia | Gastrointestinal disorders | Atomoxetine | 4 | 45 | 5 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 21 | 45 | 24 | ClinicalTrials.gov |
| other | Stomach discomfort | Gastrointestinal disorders | Atomoxetine | 3 | 45 | 3 | ClinicalTrials.gov |
| other | Malaise | General disorders | Atomoxetine | 6 | 45 | 6 | ClinicalTrials.gov |
| other | Pyrexia | General disorders | Atomoxetine | 3 | 45 | 3 | ClinicalTrials.gov |
| other | Thirst | General disorders | Atomoxetine | 9 | 45 | 9 | ClinicalTrials.gov |
| other | Nasopharyngitis | Infections and infestations | Atomoxetine | 16 | 45 | 18 | ClinicalTrials.gov |
| other | Electrocardiogram QT prolonged | Investigations | Atomoxetine | 3 | 45 | 3 | ClinicalTrials.gov |
| other | Weight decreased | Investigations | Atomoxetine | 6 | 45 | 6 | ClinicalTrials.gov |
| other | Anorexia | Metabolism and nutrition disorders | Atomoxetine | 9 | 45 | 9 | ClinicalTrials.gov |
| other | Decreased appetite | Metabolism and nutrition disorders | Atomoxetine | 4 | 45 | 4 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | Atomoxetine | 4 | 45 | 4 | ClinicalTrials.gov |
| other | Dysgeusia | Nervous system disorders | Atomoxetine | 3 | 45 | 4 | ClinicalTrials.gov |
| other | Headache | Nervous system disorders | Atomoxetine | 11 | 45 | 11 | ClinicalTrials.gov |
| other | Somnolence | Nervous system disorders | Atomoxetine | 9 | 45 | 10 | ClinicalTrials.gov |
| other | Tremor | Nervous system disorders | Atomoxetine | 3 | 45 | 3 | ClinicalTrials.gov |
| other | Insomnia | Psychiatric disorders | Atomoxetine | 3 | 45 | 3 | 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 | 45 | 45 | ClinicalTrials.gov |
| Total, serious adverse events | Atomoxetine | 0 | 45 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 21265936 | RESULT | PubMed |
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)