Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD
Interventions
DRUGAtomoxetine
40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
Sponsors
Eli Lilly and Company
Study design
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age * meet Conners' Adult ADHD Diagnostic Interview for DSM-IV™ (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood * have a Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater
Exclusion criteria
* Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the Hamilton Depression Rating Scale-17 items (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1. * Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited. * Patients who have any history of bipolar disorder (DSM-IV), any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study. * Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events Leading to Discontinuation | over 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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). |
| 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). |
| 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. |
| 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. |
| 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). |
| 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%. |
| 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. |
| 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. |
| 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine 40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Atomoxetine |
|---|---|
| Age Continuous | 33.12 years STANDARD_DEVIATION 8.97 |
| Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale | 5.0 units on a scale STANDARD_DEVIATION 0.8 |
| Conners' Adult ADHD Rating Scale-Inv:SV-J ADHD Index Subscale | 22.3 units on a scale STANDARD_DEVIATION 5.7 |
| Conners' Adult ADHD Rating Scale-Inv:SV-J Hyperactive/Impulsive Subscale | 9.8 units on a scale STANDARD_DEVIATION 6.2 |
| Conners' Adult ADHD Rating Scale-Inv:SV-J Inattentive Subscale | 21.5 units on a scale STANDARD_DEVIATION 3 |
| Conners' Adult ADHD Rating Scale-Inv:SV-J Total Symptoms Score | 31.2 units on a scale STANDARD_DEVIATION 7 |
| Conners' Adult ADHD Rating Scale-S:SV-J ADHD Index Subscale | 21.0 units on a scale STANDARD_DEVIATION 6.8 |
| Conners' Adult ADHD Rating Scale-S:SV-J Hyperactive/Impulsive Subscale | 10.1 units on a scale STANDARD_DEVIATION 5.8 |
| Conners' Adult ADHD Rating Scale-S:SV-J Inattentive Subscale | 19.0 units on a scale STANDARD_DEVIATION 5.7 |
| Conners' Adult ADHD Rating Scale-S:SV-J Total Symptoms Score | 29.1 units on a scale STANDARD_DEVIATION 9.7 |
| Hamilton Anxiety Rating Scale-14 Items Total Score | 6.2 units on a scale STANDARD_DEVIATION 5.3 |
| Hamilton Depression Rating Scale-17 Items Total Score | 4.2 units on a scale STANDARD_DEVIATION 3.9 |
| Race/Ethnicity Japanese | 45 participants |
| Region of Enrollment Japan | 45 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Number of Participants With Adverse Events Leading to Discontinuation
Time frame: over 8 weeks
Population: All three participants who discontinued due to an adverse event were on atomoxetine doses of between 80 mg/day and 105 mg/day.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Number of Participants With Adverse Events Leading to Discontinuation | Nausea | 1 participants |
| Atomoxetine | Number of Participants With Adverse Events Leading to Discontinuation | Malaise | 1 participants |
| Atomoxetine | Number of Participants With Adverse Events Leading to Discontinuation | Anorexia | 1 participants |
Secondary
Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores
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.
Time frame: baseline and 8 weeks
Population: All enrolled participants with Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | General Health Perception Baseline | 48.30 units on a scale | Standard Deviation 10.12 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | General Health Perception Change from Baseline | 0.91 units on a scale | Standard Deviation 7.21 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Mental Health Baseline | 43.18 units on a scale | Standard Deviation 10.45 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Mental Health Change from Baseline | 1.80 units on a scale | Standard Deviation 7.63 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Physical Functioning Baseline | 54.74 units on a scale | Standard Deviation 5.42 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Physical Component Summary Baseline | 47.9 units on a scale | Standard Deviation 9.52 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Physical Component Summary Change from Baseline | 1.20 units on a scale | Standard Deviation 9.64 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Mental Component Summary Baseline | 44.46 units on a scale | Standard Deviation 7.26 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Mental Component Summary Change from Baseline | 0.86 units on a scale | Standard Deviation 6.61 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Physical Functioning Change from Baseline | -0.63 units on a scale | Standard Deviation 4.94 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Role-Physical Baseline | 44.04 units on a scale | Standard Deviation 13.16 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Role-Physical Change from Baseline | 2.20 units on a scale | Standard Deviation 13.37 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Bodily Pain Baseline | 49.55 units on a scale | Standard Deviation 11.43 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Bodily Pain Change from Baseline | 0.78 units on a scale | Standard Deviation 10.28 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Vitality Baseline | 43.41 units on a scale | Standard Deviation 10.22 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Vitality Change from Baseline | 1.23 units on a scale | Standard Deviation 8.73 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Social Functioning Baseline | 43.21 units on a scale | Standard Deviation 14.31 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Social Functioning Change from Baseline | 1.17 units on a scale | Standard Deviation 13.54 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Role-Emotional Baseline | 39.09 units on a scale | Standard Deviation 14.16 |
| Atomoxetine | Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores | Role-Emotional Change from Baseline | 2.64 units on a scale | Standard Deviation 13.54 |
Secondary
Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Time frame: baseline and 8 weeks
Population: All enrolled participants with Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atomoxetine | Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity | -1.2 units on a scale | Standard Deviation 1.2 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)
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.
Time frame: baseline and 8 weeks
Population: All enrolled participants with Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | Total ADHD Symptoms Score | -15.0 units on a scale | Standard Deviation 9 |
| Atomoxetine | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | Inattentive Subscale | -9.9 units on a scale | Standard Deviation 6.7 |
| Atomoxetine | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | Hyperactivity/Impulsive Subscale | -5.0 units on a scale | Standard Deviation 4.6 |
| Atomoxetine | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) | ADHD Index Subscale | -9.3 units on a scale | Standard Deviation 6.4 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)
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.
Time frame: baseline and 8 weeks
Population: All enrolled participants with Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | Total ADHD Symptoms Score | -11.9 units on a scale | Standard Deviation 10.6 |
| Atomoxetine | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | Inattentive Subscale | -7.0 units on a scale | Standard Deviation 7 |
| Atomoxetine | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | Hyperactive/Impulsive Subscale | -4.9 units on a scale | Standard Deviation 4.8 |
| Atomoxetine | Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) | ADHD Index Subscale | -6.4 units on a scale | Standard Deviation 6.8 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score
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).
Time frame: baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atomoxetine | Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score | -0.1 units on a scale | Standard Deviation 6.2 |
p-value: 0.886t-test, 2 sided
Secondary
Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score
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).
Time frame: baseline and 8 weeks
Population: All enrolled participants with Last Observation Carried Forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atomoxetine | Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score | 0.2 units on a scale | Standard Deviation 4.2 |
p-value: 0.749t-test, 2 sided
Secondary
Change From Endpoint to Baseline in Stroop Color Word Test
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.
Time frame: baseline and 8 weeks
Population: All enrolled participants with Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Endpoint to Baseline in Stroop Color Word Test | Word Test Baseline | 91.3 number of correct answers | Standard Deviation 17.9 |
| Atomoxetine | Change From Endpoint to Baseline in Stroop Color Word Test | Word Test Change from Baseline | 4.1 number of correct answers | Standard Deviation 9.2 |
| Atomoxetine | Change From Endpoint to Baseline in Stroop Color Word Test | Color Test Baseline | 72.8 number of correct answers | Standard Deviation 14.6 |
| Atomoxetine | Change From Endpoint to Baseline in Stroop Color Word Test | Color Test Change from Baseline | 4.9 number of correct answers | Standard Deviation 7.8 |
| Atomoxetine | Change From Endpoint to Baseline in Stroop Color Word Test | Color-Word Test Baseline | 51.7 number of correct answers | Standard Deviation 11.9 |
| Atomoxetine | Change From Endpoint to Baseline in Stroop Color Word Test | Color-Word Test Change from Baseline | 4.2 number of correct answers | Standard Deviation 8.8 |
p-value: 0.005t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.003t-test, 2 sided
Secondary
Cytochrome P450 2D6 (CYP2D6) Phenotype Status
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | Poor Metabolizer | 1 participants |
| Atomoxetine | Cytochrome P450 2D6 (CYP2D6) Phenotype Status | Extensive Metabolizer | 44 participants |
Secondary
Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
The Fridericia correction of the QT interval(QTcF) was used.
Time frame: over 8 weeks
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval of >450 milliseconds (ms) | 1 participants |
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval of >480 milliseconds | 0 participants |
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval of >500 milliseconds | 0 participants |
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval increase from baseline of ≥30 msec | 4 participants |
| Atomoxetine | Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion | QTcF Interval increase from baseline of ≥60 msec | 0 participants |
Secondary
Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study
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%.
Time frame: over 8 weeks
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study | Weight Loss=Any Decrease of at Least 7% | 4 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study | Weight Gain=Any Increase of at Least 7% | 0 participants |
Secondary
Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
Vital signs reported are Pulse (beats per minute \[bpm\]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).
Time frame: over 8 weeks
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | High Pulse(bpm)=Increase ≥15 to a value >120 | 0 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Low Pulse(bpm)=Decrease ≥15 to a value <50 | 0 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | High SBP(mmHg)=Increase ≥20 to value at least 180 | 0 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Low SBP(mmHg)=Decrease ≥20 to value of at most 90 | 1 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | High DBP(mmHg)=Increase ≥15 to value at least 105 | 0 participants |
| Atomoxetine | Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study | Low DBP(mmHg)=Decrease ≥15 to value of at most 50 | 0 participants |