Trial Outcomes & Findings for Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00783835)
NCT ID: NCT00783835
Last Updated: 2013-07-23
Results Overview
Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
COMPLETED
PHASE4
60 participants
Baseline and Week 4
2013-07-23
Participant Flow
Participant milestones
| Measure |
Methylphenidate
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
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Overall Study
STARTED
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60
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Overall Study
COMPLETED
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50
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
| Measure |
Methylphenidate
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
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Overall Study
Adverse Event
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3
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Overall Study
Medical Criteria
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1
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Lost to Follow-up
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1
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Overall Study
Participant not Adherent
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3
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Baseline Characteristics
Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Methylphenidate
n=60 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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Age Continuous
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31.1 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
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Sex: Female, Male
Female
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20 Participants
n=5 Participants
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Sex: Female, Male
Male
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40 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and Week 4Population: Intent to treat efficacy evaluation (ITTe) included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
Outcome measures
| Measure |
Methylphenidate
n=58 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
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Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4
Baseline
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52.6 Unit on a scale
Standard Error 1.6
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Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4
Change at Week 4
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-10.9 Unit on a scale
Standard Error 1.6
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PRIMARY outcome
Timeframe: Baseline and Week 8Population: ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
Outcome measures
| Measure |
Methylphenidate
n=58 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
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Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8
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-16.2 Unit on a scale
Standard Error 1.6
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PRIMARY outcome
Timeframe: Baseline and Week 12Population: ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
Outcome measures
| Measure |
Methylphenidate
n=58 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
|
Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12
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-20.6 Unit on a scale
Standard Error 1.7
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PRIMARY outcome
Timeframe: Baseline and Week 4Population: ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.
Outcome measures
| Measure |
Methylphenidate
n=58 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
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Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4
Baseline
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39.6 Unit on a scale
Standard Error 2.1
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Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4
Change at Week 4
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19.4 Unit on a scale
Standard Error 2.3
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PRIMARY outcome
Timeframe: Baseline and Week 12Population: ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.
Outcome measures
| Measure |
Methylphenidate
n=58 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
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Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12
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21.9 Unit on a scale
Standard Error 2.3
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SECONDARY outcome
Timeframe: Screening (Week -2), 4, 8 and 12Population: ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = "Normal, not at all ill" and a rating of 7 = "Among the most extremely ill participants". Higher scores indicate worsening.
Outcome measures
| Measure |
Methylphenidate
n=58 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
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Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12
Screening (Week -2)
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4.6 Unit on a scale
Standard Error 0.1
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Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12
Change at Week 4
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-1.0 Unit on a scale
Standard Error 0.1
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Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12
Change at Week 8
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-1.3 Unit on a scale
Standard Error 0.1
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Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12
Change at Week 12
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-1.7 Unit on a scale
Standard Error 0.1
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SECONDARY outcome
Timeframe: Week 4, 8 and 12Population: ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).
Outcome measures
| Measure |
Methylphenidate
n=58 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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Clinical Global Impression-Improvement (CGI-I) Score
Week 4
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2.7 Unit on a scale
Standard Error 0.1
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Clinical Global Impression-Improvement (CGI-I) Score
Week 8
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2.4 Unit on a scale
Standard Error 0.1
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Clinical Global Impression-Improvement (CGI-I) Score
Week 12
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2.2 Unit on a scale
Standard Error 0.1
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SECONDARY outcome
Timeframe: Baseline, Week 4, 8 and 12Population: ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants.
Outcome measures
| Measure |
Methylphenidate
n=58 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
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Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
State Anxiety Score: Baseline
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50.4 Unit on a scale
Standard Error 1.4
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Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
Trait Anxiety Score: Baseline
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52.7 Unit on a scale
Standard Error 1.5
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Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
State Anxiety Score: Change at Week 4
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-6.1 Unit on a scale
Standard Error 1.2
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Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
Trait Anxiety Score: Change at Week 4
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-8.4 Unit on a scale
Standard Error 1.3
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Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
State Anxiety Score: Change at Week 8
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-7.8 Unit on a scale
Standard Error 1.3
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Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
Trait Anxiety Score: Change at Week 8
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-8.4 Unit on a scale
Standard Error 1.3
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Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
State Anxiety Score: Change at Week 12
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-9.4 Unit on a scale
Standard Error 1.3
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Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
Trait Anxiety Score: Change at Week 12
|
-10.7 Unit on a scale
Standard Error 1.3
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SECONDARY outcome
Timeframe: Screening (Week -2), 4 and 12Population: ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening.
Outcome measures
| Measure |
Methylphenidate
n=58 Participants
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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|---|---|
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Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12
Screening (Week -2)
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5.9 Unit on a scale
Standard Error 0.6
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Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12
Change at Week 4
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-2.8 Unit on a scale
Standard Error 0.6
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Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12
Change at Week12
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-3.3 Unit on a scale
Standard Error 0.6
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Adverse Events
Methylphenidate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methylphenidate
n=60 participants at risk
Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
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Cardiac disorders
Tachycardia
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15.0%
9/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
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Gastrointestinal disorders
Dry mouth
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23.3%
14/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
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General disorders
Irritability
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13.3%
8/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
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Infections and infestations
Nasopharyngitis
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10.0%
6/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
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Metabolism and nutrition disorders
Decreased appetite
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31.7%
19/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
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Gastrointestinal disorders
Nausea
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6.7%
4/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
|
|
Nervous system disorders
Headache
|
30.0%
18/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
|
|
Nervous system disorders
Somnolence
|
5.0%
3/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
|
|
Psychiatric disorders
Affect lability
|
5.0%
3/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
|
|
Psychiatric disorders
Anxiety
|
10.0%
6/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
|
|
Nervous system disorders
Initial insomnia
|
10.0%
6/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
|
|
Nervous system disorders
Insomnia
|
10.0%
6/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
|
|
Nervous system disorders
Libido decreased
|
6.7%
4/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
|
|
Nervous system disorders
Nervousness
|
5.0%
3/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
|
|
Nervous system disorders
Sleep disorder
|
5.0%
3/60 • Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
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Additional Information
Medical Manager
Janssen-Cilag Farmaceutica Ltda
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER