scholarly journals Analysis of individual items on the attention-deficit/hyperactivity disorder symptom rating scale in children and adults: the effects of age and sex in pivotal trials of lisdexamfetamine dimesylate

Author(s):  
Richard Weisler ◽  
AC Childress ◽  
Lenard Adler ◽  
Scott Kollins ◽  
David Goodman ◽  
...  
CNS Spectrums ◽  
2009 ◽  
Vol 14 (10) ◽  
pp. 573-586 ◽  
Author(s):  
Richard Weisler ◽  
Joel Young ◽  
Greg Mattingly ◽  
Joseph Gao ◽  
Liza Squires ◽  
...  

ABSTRACTObjective: To evaluate the long-term safety and effectiveness of lisdexamfetamine dimesylate (LDX) in the treatment of adults with attention-deficit/hyperactivity disorder (ADHD).Methods: Following a 4-week, placebo-controlled, double-blind trial, 349 adults with ADHD were enrolled into an open-label, single-arm study for up to 12 months. Treatment was initiated at 30 mg/day and titrated up to 70 mg/day at subsequent visits to achieve optimal effectiveness and tolerability. Safety assessments included adverse events inquiries, vital signs, and electrocardiograms while the primary effectiveness assessment was the ADHD Rating Scale (ADHD-RS) total score.Results: A total of 191 (54.7%) subjects completed the study. The most common treatment-emergent adverse events (TEAEs) were upper respiratory tract infection (21.8%), insomnia (19.5%), headache (17.2%), dry mouth (16.6%), decreased appetite (14.3%), and irritability (11.2%). Most TEAEs were mild to moderate in severity. At endpoint, small but statistically significant increases in pulse and blood pressure were noted. Significant improvements in mean ADHD-RS total scores were observed at week 1 and sustained throughout the study (P<.0001 at all postbaseline visits). At endpoint, the mean improvement from baseline ADHD-RS total score was 24.8 (P<.0001).Conclusions: LDX demonstrated a safety profile consistent with long-acting stimulant use and provided continued effectiveness in adults with ADHD for up to 12 months.


CNS Spectrums ◽  
2010 ◽  
Vol 15 (9) ◽  
pp. 559-568 ◽  
Author(s):  
Robert L. Findling ◽  
Ben Adeyi ◽  
Gary Chen ◽  
Bryan Dirks ◽  
Thomas Babcock ◽  
...  

ABSTRACTObjective: To examine clinical response and symptomatic remission in two studies of lisdexamfetamine dimesylate (LDX) in children with attention-deficit/hyperactivity disorder (ADHD).Methods: In a 4-week, placebo-controlled, double-blind trial, children 6–12 years of age with ADHD received LDX (30–70 mg/day) or placebo. In an open-label trial, children from previous studies were titrated to optimal dose over 4 weeks and maintained up to 1 year. Primary and secondary efficacy assessments were the ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions-Improvement (CGI-I) scale, respectively. Clinical response was defined as ≥30% reduction in ADHD-RS-IV total score with a CGI-I rating of 1 or 2; symptomatic remission was defined by ADHD-RS-IV total score ≤18.Results: In the 4-week study (N=285), at any postdose assessment, 79.3% achieved response (median 13 days) and 67.1% achieved remission (median 22 days) with LDX versus 29.2% and 23.6% with placebo. In the long-term study (N=251), at any postdose assessment, 96.0% responded and 62.7% maintained response; 88.8% achieved remission and 46.4% maintained remission.Conclusion: Most children treated with LDX achieved clinical response and symptomatic remission at one time point; once achieved, almost half maintained remission.


CNS Spectrums ◽  
2008 ◽  
Vol 13 (7) ◽  
pp. 614-620 ◽  
Author(s):  
Robert L. Findling ◽  
Ann C. Childress ◽  
Suma Krishnan ◽  
James J. McGough

ABSTRACTIntroduction:Lisdexamfetamine dimesylate (LDX), a prodrug stimulant, is indicated for attention-deficit/hyperactivity disorder (ADHD) in children 6–12 years of age and in adults. In shortterm studies, once-daily LDX provided efficacy throughout the day. This study presented here was conducted to assess the long-term safety, tolerability, and effectiveness of LDX in 6- to 12-year-olds with ADHD.Methods:This open-label, multicenter, singlearm study enrolled children with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for ADHD. Following 1-week screening and washout periods, subjects were titrated to LDX 30, 50, or 70 mg/day over 4 weeks and placed on maintenance treatment for 11 months. The ADHD Rating Scale and Clinical Global Impression-Improvement scale measured effectiveness.Results:Of 272 subjects receiving LDX, 147 completed the study. Most adverse events were mild to moderate and occurred during the first 4 weeks. There were no clinically meaningful changes in blood pressure or electrocardiographic parameters. From baseline to endpoint, mean ADHD Rating Scale scores improved by 27.2 points (P<.0001). Improvements occurred during each of the first 4 weeks, and were maintained throughout. Based on Clinical Global Impression-Improvement scale scores, >80% of subjects at endpoint and >95% of completers at 12 months were rated “improved.”Conclusion:Long-term 30, 50, and 70 mg/day LDX was generally well tolerated and effective in children with ADHD.


2019 ◽  
pp. 85-91
Author(s):  
Dinh Duong Le ◽  
Van Thang Vo ◽  
Thi Mai Nguyen ◽  
Thi Han Vo ◽  
Huu Chau Duc Nguyen ◽  
...  

Objectives: The study aims to explore the prevalence of attention deficit hyperactivity disorder and to examine the associated factors with ADHD among primary students by Vanderbilt ADHD rating scale for teacher and parents. Methods: A cross-sectional study design was conducted in 564 students who selected randomly in 4 primary schools in Hue city. Vanderbilt ADHD rating scale for parents and teachers were applied to evaluate the ADHD of children over 6 months ago. Results: The overall prevalence of children who had high risk with ADHD was 4.1% (95%CI: 2.44 - 5.72), including 4.6% and 4.8% in the rating of teachers and parents, respectively. Male was more likely to have ADHD than female (OR adj: 4.64 (95%CI: 1.53 - 14.05) and lack of closely friend (OR adj: 5.11 (95% CI: 2.13 - 12.24). Conclusion: Vanderbilt ADHD diagnosis rating scale for teachers and parents can be used to early recognization children with a high risk of ADHD. Key words: ADHD, Vanderbilt, ratings scale, teacher, parent, children


Scientifica ◽  
2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Mostafa Sadeghi ◽  
Homayoun Sadeghi-Bazargani ◽  
Shahrokh Amiri

Background. The Barkley Adult Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV (BAARS-IV) was developed, and it demonstrated good psychometric properties. The BAARS-IV includes 27 questions on the symptoms of adult ADHD. The purpose of the present study is to investigate the psychometric testing of the Persian version of BAARS-IV among the elderlies in Tabriz City. Method. This cross-sectional study was conducted in Tabriz City—in the west of Iran—in 2015 via enrolling of 121 old-aged people. We did the process of translation and adaptation of BAARS-IV and examined its concurrent validity, internal consistency, and test-retest reliability. Result. The BAARS-IV demonstrated good internal consistency and test-retest reliability. Correlations between the BAARS-IV and the CAARS-S: SV were high and evidence supporting concurrent validity was revealed. Cronbach’s alpha for the overall scale and subscales stood at 0.89, 0.81, 0.66, 0.56, and 0.82, respectively. Conclusion. The Persian BAARS-IV showed acceptable reliability and validity. BAARS-IV was determined to be composed of internally consistent and psychometrically sound items.


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