scholarly journals Efficacy and safety of methylphenidate in 45 adults with attention-deficit/hyperactivity disorder. A randomized placebo-controlled double-blind cross-over trial

2004 ◽  
Vol 34 (6) ◽  
pp. 973-982 ◽  
Author(s):  
J. J. S. KOOIJ ◽  
H. BURGER ◽  
A. M. BOONSTRA ◽  
P. D. VAN DER LINDEN ◽  
L. E. KALMA ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Response Rates ◽  
Dose Titration ◽  
Future Research ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Co Morbidity ◽  
The Impact

Background. Data on the efficacy and safety of methylphenidate in adults with attention deficit/hyperactivity disorder (ADHD) are lacking in Europe. This study was undertaken to report on the efficacy and safety of methylphenidate in an adult out-patient population with ADHD, and to compare results with US data.Method. A double-blind randomized cross-over trial comparing methylphenidate and placebo in 45 adults with ADHD with childhood onset was performed in a dose–titration design. Methylphenidate was titrated from 0·5 mg/kg per day in week 1 up to 1·0 mg/kg per day in week 3.Results. Response rates using methylphenidate varied between 38 and 51%, and using placebo between 7 and 18% (p<0·05), depending on outcome measure used. Although the overall percentage of subjects having any side effect on both methylphenidate and placebo was rather high, side effects on methylphenidate over and above those on placebo were few and mild.Conclusions. Methylphenidate proves to be an effective and well tolerated treatment for symptoms of ADHD in adults in the short term. Future research should study the long-term response and clarify the impact of gender, co-morbidity, socio-economic status and IQ on response rates in adults with ADHD.

Atomoxetine versus Methylphenidate in Paediatric Outpatients with Attention Deficit Hyperactivity Disorder: A Randomized, Double-Blind Comparison Trial

2007 ◽  
Vol 41 (3) ◽  
pp. 222-230 ◽  
Author(s):  
Yufeng Wang ◽  
Yi Zheng ◽  
Yasong Du ◽  
Dong H. Song ◽  
Yee-Jin Shin ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Rating Scale ◽  
Response Rates ◽  
Double Blind Study ◽  
Adhd Symptoms ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
End Point ◽  
Blind Comparison

Objective: To (i) test whether atomoxetine is non-inferior to methylphenidate in treating symptoms of attention deficit hyperactivity disorder (ADHD) in paediatric patients; and (ii) determine the tolerability of the two drugs. Method: This double-blind study was conducted in 6- to 16-year-old outpatients with ADHD (DSM-IV) in China, Korea and Mexico (January–October 2004). Patients were randomly assigned to once-daily atomoxetine (0.8–1.8 mg kg−1 day−1; n = 164) or twice-daily methylphenidate (0.2–0.6 mg kg−1 day−1; n = 166) for ∼8 weeks. Primary efficacy assessment was the comparison of response rates (≥40% reduction from baseline to end point in total score) on the Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and -Scored. Tolerability measures included, but were not limited to, the assessment of treatment-emergent adverse events (TEAEs) and weight. Results: Atomoxetine was non-inferior to methylphenidate in improving ADHD symptoms based on response rates (atomoxetine, 77.4%; methylphenidate, 81.5%; one-sided 95% lower confidence limit = −11.7%, p = 0.404). Treatment-emergent adverse effects experienced significantly more frequently in the atomoxetine group, compared with the methylphenidate group, included anorexia (37.2% vs. 25.3%; p = 0.024), nausea (20.1% vs. 10.2%; p = 0.014), somnolence (26.2% vs. 3.6%; p <0.001), dizziness (15.2% vs. 7.2%; p = 0.024) and vomiting (11.6% vs. 3.6%; p = 0.007), most of which were of mild or moderate severity. Atomoxetine-treated patients experienced a small but significantly greater mean weight loss from baseline to end point than methylphenidate-treated patients (−1.2 kg vs. −0.4 kg; p <0.001). Conclusions: This study suggests that atomoxetine is non-inferior to methylphenidate in the improvement of ADHD symptoms in paediatric outpatients. Although both of the drugs were well tolerated, atomoxetine was associated with a higher incidence of TEAEs than methylphenidate.

scholarly journals Functional improvement and correlations with symptomatic improvement in adults with attention deficit hyperactivity disorder receiving long-acting methylphenidate

2011 ◽  
Vol 42 (1) ◽  
pp. 195-204 ◽  
Author(s):  
J. K. Buitelaar ◽  
M. Casas ◽  
A. Philipsen ◽  
J. J. S. Kooij ◽  
J. A. Ramos-Quiroga ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Daily Functioning ◽  
Open Label ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Co Morbidity ◽  
Open Label Extension

BackgroundData on the relationship between core symptoms and daily functioning in adults with attention deficit hyperactivity disorder (ADHD) are limited. Daily functioning was assessed as part of an open-label extension, and associations with symptom scores were evaluated.MethodAfter a 5-week double-blind study with adults with ADHD receiving osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) 18, 36 or 72 mg/day, or placebo, participants were eligible for a 7-week open-label extension in which all patients received OROS MPH. Data for the Conners' Adult ADHD Rating Scale – Observer: Screening Version (CAARS-O:SV) (primary endpoint) have been presented previously. Secondary endpoints included the observer self-reported short version of the CAARS (CAARS-S:S) and the Clinical Global Impressions – Severity Scale (CGI-S). Daily functioning and quality of life were assessed using the Sheehan Disability Scale (SDS) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) respectively. In post-hoc analyses, changes in CAARS-O:SV were evaluated in subgroups. Relationships between symptom and functional outcomes were evaluated in a multivariate regression analysis.ResultsA total of 370 patients entered the open-label extension. Significant improvements from baseline in CAARS-O:SV were similar regardless of sex, ADHD subtype, prior treatment or psychiatric co-morbidity. Significant improvements from double-blind baseline were also seen for the CAARS-S:S, CGI-S, SDS and Q-LES-Q. Improvements in the CAARS-O:SV Hyperactivity/Impulsivity subscale were associated with improvements in SDS total and subscale scores, and in the Q-LES-Q score at open-label endpoint. Improvements in CAARS-O:SV Inattention subscale and CGI-S scores were not significantly associated with functional changes.ConclusionsImprovements in ADHD symptoms relating to hyperactivity and impulsivity in adults receiving OROS MPH are associated with improvements in daily functioning and quality of life.

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