This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
299
Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose.
Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.
Time frame: Week 40 - Week 66
Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.
Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 ("rarely or never") to 3 ("Very often"). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing.
Time frame: week 40 - week 66
Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score
SDS,5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores\>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.
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Novartis Investigative Site
Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Spring Valley, California, United States
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Bradenton, Florida, United States
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Orlando, Florida, United States
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West Plam Beach, Florida, United States
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Libertyville, Illinois, United States
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Owensboro, Kentucky, United States
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Las Vegas, Nevada, United States
Novartis Investigative Site
Las Vegas, Nevada, United States
...and 38 more locations
Time frame: week 40 - week 66