Attention-Deficit/Hyperactivity Disorder
Conditions
Keywords
ADHD
Brief summary
This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
Interventions
DRUGLisdexamfetamine Dimesylate
Oral 30, 50, or 70mg once-daily for 9 weeks
DRUGAtomoxetine Hydrochloride
Oral 10mg to 100mg once-daily for 9 weeks
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subject has had an historical or current inadequate response to methylphenidate (MPH) treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative drug treatment to MPH therapy. * Subject is a male or female aged 6-17 years inclusive at the time of consent * Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition. - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation * Subject must have a baseline ADHD-RS-IV total score 28.
Exclusion criteria
* Subject has taken more than 1 MPH treatment (for example, 2 or more different MPH treatments). Examples include but are not limited to RITALIN immediate release (IR) and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long-acting LA and CONCERTA. Note: this does not include subjects who have taken IR MPH for dose titration on a short-term basis (for example, £4 weeks) with an adequate response * In the Investigator's judgement, subject has failed to respond to more than 1 previous course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms. * Subject has previously been exposed to STRATTERA or to amphetamine therapy * Subject has previously demonstrated intolerable side effects to 1 MPH treatment which limited titration to acceptable efficacy or that required a decrease in dose resulting in unacceptable tolerability and/or efficacy * Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments. * Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Response | 9 weeks | Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF | Baseline and 9 weeks | ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology. |
| Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks | Baseline and up to 9 weeks | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. |
| Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks | up to 9 weeks | HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. |
| Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF) | 9 weeks | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | 9 weeks | C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. |
| Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | 9 weeks | UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product. |
| Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks | Baseline and up to 9 weeks | The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. |
Countries
Belgium, Canada, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lisdexamfetamine Dimesylate Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg. | 128 |
| Atomoxetine Hydrochloride Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg. | 134 |
| Total | 262 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 10 |
| Overall Study | Early Termination Requested By Sponsor | 1 | 0 |
| Overall Study | Hard Time Swallowing The Pills | 1 | 0 |
| Overall Study | Lack of Efficacy | 2 | 13 |
| Overall Study | Lost to Follow-up | 5 | 1 |
| Overall Study | Moved Out Of State | 0 | 1 |
| Overall Study | Noncompliance | 0 | 1 |
| Overall Study | Previous Use Of Marijuana | 1 | 0 |
| Overall Study | Protocol Violation | 7 | 2 |
| Overall Study | Refused To Take Medication | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 4 |
Baseline characteristics
| Characteristic | Lisdexamfetamine Dimesylate | Atomoxetine Hydrochloride | Total |
|---|---|---|---|
| Age, Continuous | 10.9 Years STANDARD_DEVIATION 3.01 | 10.4 Years STANDARD_DEVIATION 2.84 | 10.6 Years STANDARD_DEVIATION 2.93 |
| Age, Customized 13 - 17 years | 34 Participants | 34 Participants | 68 Participants |
| Age, Customized 6 - 12 years | 94 Participants | 100 Participants | 194 Participants |
| Region of Enrollment BELGIUM | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment CANADA | 17 Participants | 18 Participants | 35 Participants |
| Region of Enrollment GERMANY | 20 Participants | 22 Participants | 42 Participants |
| Region of Enrollment HUNGARY | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment ITALY | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment POLAND | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment SPAIN | 12 Participants | 10 Participants | 22 Participants |
| Region of Enrollment SWEDEN | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment UNITED STATES | 70 Participants | 68 Participants | 138 Participants |
| Sex: Female, Male Female | 34 Participants | 31 Participants | 65 Participants |
| Sex: Female, Male Male | 94 Participants | 103 Participants | 197 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 92 / 128 | 95 / 134 |
| serious Total, serious adverse events | 0 / 128 | 0 / 134 |
Outcome results
Primary
Time to First Response
Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: 9 weeks
Population: Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. One subject was randomized to receive Strattera, but actually received Lisdexamfetamine Dimesylate. For all efficacy analyses this subject is included in the Strattera arm per the intention to treat principle.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lisdexamfetamine Dimesylate | Time to First Response | 12.0 Days |
| Atomoxetine Hydrochloride | Time to First Response | 21.0 Days |
p-value: =0.001Peto-Peto-Prentice Wilcoxon Test
Secondary
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF
ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.
Time frame: Baseline and 9 weeks
Population: Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF | -26.1 units on a scale | Standard Error 1.16 |
| Atomoxetine Hydrochloride | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF | -19.7 units on a scale | Standard Error 1.13 |
p-value: <0.00195% CI: [-9.3, -3.6]ANCOVA
Secondary
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks
The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
Time frame: Baseline and up to 9 weeks
Population: Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks | -10.7 units on a scale | Standard Deviation 9.27 |
| Atomoxetine Hydrochloride | Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks | -7.9 units on a scale | Standard Deviation 9.07 |
Secondary
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Time frame: Baseline and up to 9 weeks
Population: Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks | -0.35 units on a scale | Standard Error 0.034 |
| Atomoxetine Hydrochloride | Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks | -0.27 units on a scale | Standard Error 0.032 |
p-value: 0.04695% CI: [-0.17, 0]ANCOVA
Secondary
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Time frame: 9 weeks
Population: Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation | 0 participants |
| Lisdexamfetamine Dimesylate | Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior | 0 participants |
| Atomoxetine Hydrochloride | Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation | 0 participants |
| Atomoxetine Hydrochloride | Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior | 0 participants |
Secondary
Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks
HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
Time frame: up to 9 weeks
Population: Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks | 0.920 units on a scale | Standard Deviation 0.0961 |
| Atomoxetine Hydrochloride | Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks | 0.922 units on a scale | Standard Deviation 0.0937 |
Secondary
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: 9 weeks
Population: Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lisdexamfetamine Dimesylate | Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF) | 81.7 percentage of participants |
| Atomoxetine Hydrochloride | Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF) | 63.6 percentage of participants |
p-value: 0.00195% CI: [7.5, 28.7]Cochran-Mantel-Haenszel
Secondary
Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1
UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product.
Time frame: 9 weeks
Population: Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Akathisia | 0 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Depression | 6 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Paraesthesias | 1 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Tension/Inner Unrest | 20 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Accomodation Disturbances | 0 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Increased Duration of Sleep | 12 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Increased Salivation | 1 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Reduced Salivation | 16 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Diarrhea | 6 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Increased Dream Activity | 3 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Constipation | 9 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Asthenia/Lassitude/Increased Fatigability | 25 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Micturition Disturbances | 0 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Emotional Indifference | 12 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Polyuria/Polydipsia | 3 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Headache-Tension Headache | 15 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Orthostatic Dizziness | 10 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Dystonia | 0 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Palpitations/Tachycardia | 1 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Nausea/Vomiting | 19 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Increased Tendency to Sweating | 3 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rigidity | 0 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rash-Morbiliform | 0 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Concentration Difficulties | 75 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rash-Petechial | 1 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Hypokinesia/Akinesia | 1 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rash-Urticarial | 1 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Reduced Duration of Sleep | 29 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rash-Cannot be Classified | 1 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Hyperkinesia Logic | 2 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Pruritus | 4 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Failing Memory | 10 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Weight Gain | 1 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Tremor | 3 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Headache-Migraine | 2 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Sleepiness/Sedation | 16 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Headache-Other Forms | 11 participants |
| Lisdexamfetamine Dimesylate | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Weight Loss | 46 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Headache-Other Forms | 10 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Weight Loss | 19 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Reduced Duration of Sleep | 16 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Asthenia/Lassitude/Increased Fatigability | 29 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Tension/Inner Unrest | 22 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Nausea/Vomiting | 26 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Sleepiness/Sedation | 35 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Reduced Salivation | 6 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Headache-Tension Headache | 17 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Concentration Difficulties | 92 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Failing Memory | 21 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Depression | 10 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Increased Duration of Sleep | 12 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Increased Dream Activity | 8 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Emotional Indifference | 10 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Dystonia | 1 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rigidity | 1 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Hypokinesia/Akinesia | 0 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Hyperkinesia Logic | 3 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Tremor | 1 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Akathisia | 2 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Paraesthesias | 0 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Accomodation Disturbances | 2 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Increased Salivation | 2 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Diarrhea | 9 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Constipation | 5 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Micturition Disturbances | 1 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Polyuria/Polydipsia | 2 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Orthostatic Dizziness | 9 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Palpitations/Tachycardia | 5 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Increased Tendency to Sweating | 5 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rash-Morbiliform | 1 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rash-Petechial | 0 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rash-Urticarial | 1 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Rash-Cannot be Classified | 2 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Pruritus | 7 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Weight Gain | 0 participants |
| Atomoxetine Hydrochloride | Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 | Headache-Migraine | 2 participants |