scholarly journals Effect of a Multilayer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial Followed by a 6-Month Open-Label Follow-Up

2021 ◽  
Author(s):  
Margaret Danielle Weiss ◽  
Craig Surman ◽  
Atul Khullar ◽  
Judith Owens ◽  
Ellie He ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Extended Release ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Open Label ◽  
Double Blind ◽  
Hyperactivity Disorder

scholarly journals Characteristics of ADHD Symptom Response/Remission in a Clinical Trial of Methylphenidate Extended Release

2019 ◽  
Vol 8 (4) ◽  
pp. 461 ◽  
Author(s):  
Margaret Weiss ◽  
Ann Childress ◽  
Earl Nordbrock ◽  
Akwete Adjei ◽  
Robert Kupper ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Extended Release ◽  
Rating Scale ◽  
Phase Iii ◽  
Open Label ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Percent Change

Clinical trials in attention-deficit/hyperactivity disorder (ADHD) have typically measured outcome using clinician ratings on the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) and the Clinical Global Impression-Improvement (CGI-I) scale. Remission has been defined as an endpoint score of less than or equal to 18 on the ADHD-RS-IV (or a mean score of 1). Responders have been defined as patients who achieve a CGI-I score of much or very much improved (1 or 2). There is a lack of agreement in the literature on what percent change in symptoms on the ADHD-RS-IV should be used to define improvement or remission. This study uses data from a clinical trial of a methylphenidate extended release (MPH-MLR; Aptensio XR®) phase III clinical trial to attempt to determine the percent change of symptoms that best corresponds with improvement and remission. Symptom remission at endpoint (ADHD-RS-IV total score ≤18) was most closely aligned with a ≥46% reduction in ADHD-RS-IV total score. Clinical improvement was most closely aligned with a ≥40% reduction in ADHD-RS-IV total score. The three different measures of outcome were strongly aligned during double blind and open label treatment, and were independent of subtype status. Our data suggest that at least 40% improvement in symptoms is needed to achieve a robust response at endpoint.

scholarly journals 1-year follow-up of neurofeedback treatment in adolescents with attention-deficit hyperactivity disorder: randomised controlled trial

BJPsych Open ◽  
2016 ◽  
Vol 2 (2) ◽  
pp. 107-115 ◽  
Author(s):  
Marleen Bink ◽  
Ilja L. Bongers ◽  
Arne Popma ◽  
Tieme W. P. Janssen ◽  
Chijs van Nieuwenhuizen
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Randomised Controlled Trial ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Treatment As Usual ◽  
Hyperactivity Disorder ◽  
Study Results ◽  
Randomised Controlled ◽  
Neurocognitive Measures

BackgroundEstimates of the effectiveness of neurofeedback as a treatment for attention-deficit hyperactivity disorder (ADHD) are mixed.AimsTo investigate the long-term additional effects of neurofeedback (NFB) compared with treatment as usual (TAU) for adolescents with ADHD.MethodUsing a multicentre parallel-randomised controlled trial design, 60 adolescents with a DSM-IV-TR diagnosis of ADHD receiving NFB+TAU (n=41) or TAU (n=19) were followed up. Neurofeedback treatment consisted of approximately 37 sessions of theta/sensorimotor rhythm (SMR)-training on the vertex (Cz). Outcome measures included behavioural self-reports and neurocognitive measures. Allocation to the conditions was unmasked.ResultsAt 1-year follow-up, inattention as reported by adolescents was decreased (range ηp2=0.23–0.36, P<0.01) and performance on neurocognitive tasks was faster (range ηp2=0.20–0.67, P<0.005) irrespective of treatment group.ConclusionsOverall, NFB+TAU was as effective as TAU. Given the absence of robust additional effects of neurofeedback in the current study, results do not support the use of theta/SMR neurofeedback as a treatment for adolescents with ADHD and comorbid disorders in clinical practice.

Sign in / Sign up

Export Citation Format

Share Document