Active clinical trials for "Hyperkinesis"

While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks. A number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population. In order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404. Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) after a single dose of JNJ-31001074. Up to three dose strengths will be tested in patients 6-11 years old with attention deficit hyperactivity disorder (ADHD).

Attention deficit with hyperactivity disorder (ADHD) is a very common behavioral problem during childhood. It is estimated that up to 80% of this disorder could be related to genetic factors. The most common treatment for ADHD is psychostimulants. In this study, the researchers investigate the effect of genetic variants in increasing the risk for behaviours pertinent to ADHD or in modulating the response of these behaviours to methylphenidate. Response to methylphenidate is evaluated through a double blind placebo controlled one week study.

In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders. These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.).

This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years, with various types of attention training. Different groups A, B and C will be evaluated: the first with Neurofeedback training, the second with a similar training but not indexed on brain activity and the third without training. 30 patients will be randomly assigned to groups A and B according to a ratio 2:1. Others patients who meet the same criteria but for logistical reasons cannot comply with the training constraints will be assigned to group C. Children included in groups A and B will participate in training sessions (Neurofeedback and control training, respectively) as well as in four evaluation sessions. Children in group C will only participate in evaluation sessions (baseline control group). Patients of groups A and B will be followed over 6 months: 4 months of training and a follow-up evaluation 2 months after training. Patients of group C will be followed each 2 months for 6 months. This study uses electro-encephalography measures, serious video game, neuropsychological tests and questionnaires. It also uses actigraphy measures to evaluate sleep quality.

This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD. Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD (combined, inattentive or hyperactive/impulsive) will be enrolled. There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include washout if applicable, an enrollment & parent training phase lasting 2-4 weeks, an eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a 6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR® responders, and a two-week follow-up call after study completion or early discontinuation to assess for ongoing adverse events and concomitant medications. Up to 150 subjects will be enrolled in this trial to allow for subjects who improve significantly during the behavior training phase and drop-outs. Once 74 subjects have completed the double-blind phase, no additional subjects will be enrolled in the trial. Subjects who are already enrolled at that time will be allowed to complete the trial. The primary objective of this study is to establish that an optimal dose of Aptensio XR® will result in a significant reduction in ADHD symptoms compared with placebo in children ages 4 to under 6 years.

The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.

Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of neuropsychological dysfunction including response inhibition, working memory, and attention. One neuropsychological outcome measure that consistently reveals between-group differences is response variability. However, until recently, differences in response variability have been reported as an ancillary finding or viewed as a nuisance in the analyses. The specific aims of the present study are to 1) Examine response variability in ADHD patients across neuropsychological tasks to understand the breadth of this specific deficit and to understand the relation between response variability and other neuropsychological outcome measures; 2) Assess whether response variability deficits are specific to either or both of the two most prevalent ADHD subtypes (i.e., Combined Type [CT] and Predominantly Inattentive Type [PIT]); 3) Determine whether response variability in ADHD patients is affected by either medication or a variety of environmental manipulations (e.g., reward); and 4) Understand the relationship between neuropsychological measures of response variability and naturalistic instances of variable performance. Forty-five children (aged 7-11) with ADHD-CT, 45 children with ADHD-PIT, and 45 normal controls will be recruited to examine response variability across a wide range of neuropsychological tests. Task parameters such as event rate, stimulus saliency, and the presence of operant reward will be modified on each test to determine the conditions under which response variability is manifested in children with ADHD. In addition, all children with ADHD will participate in a placebo-controlled, randomized medication trial with a psychostimulant medication to assess the effects of medication on response variability. Advanced analytic methods utilizing non-Gaussian distributions and fast Fourier Transforms of the reaction time data will be used to conduct detailed analyses of RT patterns across the ADHD and normal control groups. Further, the effects of task parametric manipulations and medication on response variability will be examined. Finally, relations between response variability on neuropsychological tests and response variability in a variety of real-world analog situations will be examined to evaluate the ecological validity of these deficits.

Peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. Peer co-led education is included in the Norwegian national guidelines for treatment of mental disorders, but despite some promising results for the treatment of other conditions, still little is known about the efficacy of peer co-led educational group interventions interventions for adults with attention deficit and hyperactivity disorder (ADHD). This pilot trial will evaluate patient satisfaction with and preliminary efficacy of a 2-session peer co-led educational group program designed to address specific challenges faced by adults diagnosed with ADHD at an outpatient clinics in mid-Norway.

This study investigates whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with Attention Deficit Hyperactivity Disorder (ADHD).