EEG-MRI Imaging of Methylphenidate Effects in Adult ADHD and Attentional Symptoms in Mood Disorders...
Adult ADHDAdult-onset ADHD With Mood DisorderAttention Deficit Hyperactivity Disorder (ADHD) in adults is a common psychiatric disorder, with important consequences in terms of quality of life, mental health (associated disorders and poorer response to treatment), family life, risk of accidents; with a consequent cost for society. Adult ADHD is frequently associated with psychiatric co-morbidities, and notably associated with mood disorders (major depressive disorder or bipolar disorder) in about 50% of cases. The diagnosis of ADHD in adults is made in patients with an attentional complaint (pure ADHD or ADHD-P), but also very often in the management of a comorbid mood disorder (ADHD associated with mood disorder, or ADHD-MD). In this case, the ADHD had no impact during childhood and adolescence. Medication management is well established for ADHD-P, and medication is based on methylphenidate, which has a rapid and significant effect on attentional symptoms and impulsivity. However, in the case of ADHD-HD, there is little evidence of treatment efficacy and the mechanisms of action of methylphenidate at the brain level are poorly understood. The aim of the study is to determine the neural mechanisms of the effect of methylphenidate, using functional MRI and EEG, in ADHD-P and ADHD-HD patients, and to compare them to healthy subjects. A single dose allows us to observe effects that are then persistent with repeated doses. The aim is to determine, by means of a biomarker, whether methylphenidate treatment responds to the same mechanisms in the different groups and would be relevant in ADHD-P as in ADHD-HD. Main objective: To determine whether methylphenidate impacts differently on brain circuits associated with cognitive functions in the two clinical populations studied (adult ADHD patients and patients with post mood disorder attentional deficit) and in comparison to controls. Secondary objectives: To determine the effect of methylphenidate on baseline brain flow in the two clinical populations and in controls (healthy subjects). To determine whether methylphenidate has a different impact on cognitive performance in the two clinical populations studied and in comparison to controls (healthy subjects). To confirm the effect of methylphenidate on the maintenance of cortical arousal. To distinguish the brain networks impacted by methylphenidate (maintenance of attention or inhibition) with MRI and EEG.
Effect of a Self-hypnosis on Attention Disorders and Anxiety in Children With Attention Deficit/Hyperactivity...
Attention Deficit/Hyperactivity DisorderThe prevalence of Attention Deficit/ Hyperactivity (ADHD) varies between 3 and 10% depending on the studies. Comorbidities are frequently associated, in particular anxiety disorders. School, social and family consequences of ADHD can be major, especially in the presence of a comorbidity. The study goal is to evaluate, through questionnaires, the effect of self-hypnosis via a smartphone application, on the symptoms of inattention and anxiety in children with ADHD in addition to their treatment by methylphenidate. Parents and children complete the study questionnaires four times. T0: at inclusion T1 (T0+6 weeks): after 6 weeks of using the self-hypnosis application 5 days out of 7 for group 1 in parallel with the usual treatment / after 6 weeks of usual treatment for the group 2 T2 (T0+8 weeks): after a wash-out period of 2 weeks (usual treatment only) for both groups T3 (T0+14 weeks): after 6 weeks of use of the self-hypnosis application 5 days out of 7 for group 2 in parallel with the usual treatment / after 8 weeks of usual treatment for the group 1, following the 6 weeks of use of the application.
Social VR Based Intervention on Enhancing Social Interaction Skills in Children With AD/HD
Attention-Deficit/Hyperactivity DisorderThe study targets children with diagnosed ADHD and aims to (1) develop a social virtual reality based (SocVR) intervention and (2) investigate its effects on improving the social skills and executive functioning of inhibitions, emotional control and attention of the children compared to traditional social skills training. The study will be a three-arm parallel randomised controlled trial comparing the effects of a SocVR with traditional social skills training on social skills and executive functioning of children with ADHD. The study period is 2 months, including 4 weeks (2 sessions per week) of intervention and control, followed by a 4-week follow-up. The participants will be assessed at three time points (i.e. at baseline, 4 weeks and 4 weeks follow-up). The guidelines of Whitehead et al. (2016) suggested that recommended that at least 16 subjects per group for medium effect size in pilot RCT and 15% attrition over time can be expected. Thus, the minimum sample size per group was 20. A total of 60 participants will be recruited in which 20 participants in the social VR group, 20 in the traditional social skills group and 20 in the waitlist control group.
Methylphenidate and Response to Alcohol Cues (MARA) Pilot Study
Alcohol Use DisorderAttention Deficit Hyperactivity DisorderThe purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate affects responses to alcohol cues. The study will observe the effects of methylphenidate or a placebo on attentional bias and craving responses to alcohol cues through fMRI, EEG, and behavioral testing. Participants will be involved in one remote and two in-person sessions.
Impact of Combined Medication and Behavioral Treatment for ASD & ADHD
Autism Spectrum DisorderAttention Deficit Hyperactivity DisorderChildren with comorbid autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) have significantly worse outcomes than those with either ASD alone or ADHD alone. Effective early treatments that account for ADHD symptoms have not been developed for young children with ASD+ADHD. The overarching goals of this randomized, placebo-controlled, phase 2, pilot study are to (1) evaluate a novel early intervention that pharmacologically addresses ADHD symptoms while providing an ASD-targeted behavioral intervention, and (2) identify changes in behavioral and neurophysiological activity that may underlie improved outcomes in children with comorbid ASD and ADHD ages 3-10 years. The primary aim of this study is to evaluate whether a stimulant treatment augments efficacy of an ASD specific form of parent child therapy based on the Early Start Denver Model called ESDM influenced Parent Coaching. Secondary aims are to determine the efficacy of combined intervention in improving ADHD symptoms and the efficacy, safety, and tolerability of Adzenys-XR-ODT in young children with ASD+ADHD. The study will also examine correlations between behavioral changes and state-of-the-art eye-gaze tracking (EGT) and electroencephalographic (EEG) biomarkers to elucidate key ways in which ADHD impacts attentional and neural functioning in ASD+ADHD, and to potentially identify new targets for intervention in children with ASD+ADHD. The study is about 8 months long and will involve screening, baseline assessment followed by 10- 11 weeks of study drug treatment (active or placebo) and 8 sessions of ESDM informed parent coaching beginning after 2 weeks of study drug treatment, primary endpoint assessments at ~11 weeks, AE follow-up by phone at ~week 13 and remote FU 24 weeks after baseline. Eligible participants will be randomly assigned to the active medication or placebo, Between weeks 11 to 24, it is expected that the parent will use the behavioral strategies they were coached in even though they will not receive parent coaching. Participants will be given the option to pursue ADHD medication outside of the research study after week 11 assessments.
Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD
Attention Deficit Hyperactivity DisorderMultiple forms of Omega-3 Fatty acids have been used to investigate the role of this food supplement in children with Attention Deficit Hyperactivity Disorder (ADHD). No clear evidence for their role in this disorder is yet available. We will conduct a prospective, randomized, double blind, placebo controlled trial to obtain significant results regarding this question.
Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits
Traumatic Brain InjuryAttention Deficit DisorderThe purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on attention deficits caused by TBI are not known, but we expect that Vyvanse will be of some help in treating those types of problems as well. The study will utilize functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.
Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD)...
Attention Deficit Hyperactivity DisorderGlucose Intolerance1 moreThe purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese.
Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children
Attention Deficit/Hyperactivity DisorderThe purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds.
Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity...
Attention Deficit Hyperactivity Disorder (ADHD)The purpose of the study is to evaluate the long-term safety and tolerability of SHP465 at 6.25 milligram (mg) in children aged 4 to 12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).