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Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT00783835
Recruitment Status : Completed
First Posted : November 3, 2008
Results First Posted : July 23, 2013
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Farmaceutica Ltda.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Long-Acting Methylphenidate
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Methylphenidate
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 60
Completed 50
Not Completed 10
Reason Not Completed
Adverse Event             3
Medical Criteria             1
Withdrawal by Subject             2
Lost to Follow-up             1
Participant not Adherent             3
Arm/Group Title Methylphenidate
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
31.1  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
20
  33.3%
Male
40
  66.7%
1.Primary Outcome
Title Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4
Hide Description 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).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 58
Mean (Standard Error)
Unit of Measure: Unit on a scale
Baseline 52.6  (1.6)
Change at Week 4 -10.9  (1.6)
2.Primary Outcome
Title Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8
Hide Description 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).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 58
Mean (Standard Error)
Unit of Measure: Unit on a scale
-16.2  (1.6)
3.Primary Outcome
Title Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 58
Mean (Standard Error)
Unit of Measure: Unit on a scale
-20.6  (1.7)
4.Primary Outcome
Title Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4
Hide Description 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.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 58
Mean (Standard Error)
Unit of Measure: Unit on a scale
Baseline 39.6  (2.1)
Change at Week 4 19.4  (2.3)
5.Primary Outcome
Title Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 58
Mean (Standard Error)
Unit of Measure: Unit on a scale
21.9  (2.3)
6.Secondary Outcome
Title Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12
Hide Description 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.
Time Frame Screening (Week -2), 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 58
Mean (Standard Error)
Unit of Measure: Unit on a scale
Screening (Week -2) 4.6  (0.1)
Change at Week 4 -1.0  (0.1)
Change at Week 8 -1.3  (0.1)
Change at Week 12 -1.7  (0.1)
7.Secondary Outcome
Title Clinical Global Impression-Improvement (CGI-I) Score
Hide Description 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).
Time Frame Week 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 58
Mean (Standard Error)
Unit of Measure: Unit on a scale
Week 4 2.7  (0.1)
Week 8 2.4  (0.1)
Week 12 2.2  (0.1)
8.Secondary Outcome
Title Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
Hide Description 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.
Time Frame Baseline, Week 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 58
Mean (Standard Error)
Unit of Measure: Unit on a scale
State Anxiety Score: Baseline 50.4  (1.4)
Trait Anxiety Score: Baseline 52.7  (1.5)
State Anxiety Score: Change at Week 4 -6.1  (1.2)
Trait Anxiety Score: Change at Week 4 -8.4  (1.3)
State Anxiety Score: Change at Week 8 -7.8  (1.3)
Trait Anxiety Score: Change at Week 8 -8.4  (1.3)
State Anxiety Score: Change at Week 12 -9.4  (1.3)
Trait Anxiety Score: Change at Week 12 -10.7  (1.3)
9.Secondary Outcome
Title Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12
Hide Description 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.
Time Frame Screening (Week -2), 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 58
Mean (Standard Error)
Unit of Measure: Unit on a scale
Screening (Week -2) 5.9  (0.6)
Change at Week 4 -2.8  (0.6)
Change at Week12 -3.3  (0.6)
Time Frame Baseline up to end of study.
Adverse Event Reporting Description 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.
 
Arm/Group Title Methylphenidate
Hide Arm/Group Description 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.
All-Cause Mortality
Methylphenidate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Methylphenidate
Affected / at Risk (%)
Total   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methylphenidate
Affected / at Risk (%)
Total   48/60 (80.00%) 
Cardiac disorders   
Tachycardia * 1  9/60 (15.00%) 
Gastrointestinal disorders   
Dry mouth * 1  14/60 (23.33%) 
Nausea * 1  4/60 (6.67%) 
General disorders   
Irritability * 1  8/60 (13.33%) 
Infections and infestations   
Nasopharyngitis * 1  6/60 (10.00%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  19/60 (31.67%) 
Nervous system disorders   
Headache * 1  18/60 (30.00%) 
Somnolence * 1  3/60 (5.00%) 
Initial insomnia * 1  6/60 (10.00%) 
Insomnia * 1  6/60 (10.00%) 
Libido decreased * 1  4/60 (6.67%) 
Nervousness * 1  3/60 (5.00%) 
Sleep disorder * 1  3/60 (5.00%) 
Psychiatric disorders   
Affect lability * 1  3/60 (5.00%) 
Anxiety * 1  6/60 (10.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Manager
Organization: Janssen-Cilag Farmaceutica Ltda
Phone: +55 11 30302738
Layout table for additonal information
Responsible Party: Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier: NCT00783835     History of Changes
Other Study ID Numbers: CR013999
42603ATT4053
First Submitted: October 31, 2008
First Posted: November 3, 2008
Results First Submitted: March 22, 2013
Results First Posted: July 23, 2013
Last Update Posted: July 23, 2013