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NCT ID: NCT02677519 Not yet recruiting - Clinical trials for Attention Deficit Disorder With Hyperactivity

A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD

EF004
Start date: September 2016
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children aged 4-5 years who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory The primary objective of this study is to evaluate the long-term (12-month) safety and tolerability of Aptensio XR® in children aged 4 to less than 6 years who have been diagnosed with ADHD. Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory values and Columbia Suicide Severity Rating Scale (C-SSRS). Disturbances in sleep (quantity and quality) patterns will also be assessed using the Child Sleep Habits Questionnaire (CSHQ). Secondary objectives include assessment of long-term efficacy of Aptensio XR®. Secondary measures include: - Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version) - Clinical Global Impressions-Severity Scale (CGI-S ) - Connors Early Childhood Behavior-Parent Short form [Conners EC BEH-P(S)]

NCT ID: NCT02675400 Completed - Clinical trials for Attention Deficit/Hyperactivity Disorder (ADHD)

Treatments for Fathers With ADHD and Their At-Risk Children (Fathers Too)

Start date: December 2015
Phase: Phase 4
Study type: Interventional

In contrast to mothers with Attention Deficit/Hyperactivity Disorder (ADHD), the impact of paternal ADHD in families and children with ADHD symptoms has not been studied, despite the prevalence of ADHD in males. Thus, the investigators do not know the feasibility, impact on treatment on the family and child, and effects of treating fathers relative to mothers with ADHD. Paternal ADHD is associated with negative parenting and child conduct problems. The investigators hypothesize that successfully treating parental ADHD in fathers will have a beneficial effects on the family that will extend to the child. Specifically, the investigators believe that stimulant medication ((Lisdexamfetamine (LDX) or a different ADHD medication if poor response to LDX) with fathers will reduce father's ADHD symptoms and improve parenting. Effects of stimulant treatment of fathers will be compared to Behavioral Parent Training (BPT) on parenting, and paternal and child outcomes in fathers with ADHD who have children between the ages of 3 -8. As in the investigator's previous work, the investigators will bank paternal and child DNA and RNA for later examination of pharmacogenetic and epigenetic effects (i.e. RNA) of stimulant response.

NCT ID: NCT02674633 Completed - Clinical trials for Attention Deficit Disorder With Hyperactivity

Software Treatment for Actively Reducing Severity of ADHD

STARS-ADHD
Start date: May 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of videogame-like digital therapies on attentional functioning and symptoms in children diagnosed with ADHD.

NCT ID: NCT02656758 Enrolling by invitation - Clinical trials for Attention Deficit Hyperactivity Disorder

Intensive Executive Function Training

Start date: January 2016
Phase: N/A
Study type: Interventional

The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The attention deficit hyperactivity disorder families had received executive function training one year before.They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in intensive executive function training immediately,while the control group will receive executive training after 3 months.

NCT ID: NCT02655276 Completed - Clinical trials for Stress, Psychological

Sublingual Glycine vs. Placebo on Attentional Difficulties and Hyperactivity in Prepuberal Children

Start date: January 2016
Phase: N/A
Study type: Interventional

This study is designed to investigate effects on attentional performance and motoric activity of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each. The primary objective of the study is to determine the effects on attentional performance and motoric activity of 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each in children with low attentional performance and high motoric activity. A number of 30 prepuberal boys and girls aged 6 - 14 years with low attentional performance and high motoric activity will be enrolled in this study. The prepuberal status will be determined by Tanner stages ≤ 3.

NCT ID: NCT02642666 Completed - ADHD Clinical Trials

The Effects of Yoga on Attention, Impulsivity and Hyperactivity in Pre-school Age Children

Start date: December 2015
Phase: N/A
Study type: Interventional

This pilot project will evaluate yoga as an intervention to improve attention and reduce challenging behaviors such as hyperactivity and impulsivity, rated by parent and teachers, in preschool age children with or "at risk" for attention-deficit hyperactivity disorder (ADHD). "At Risk" for ADHD will be defined as four or more hyperactive/impulsive and/or inattentive symptoms on the ADHD Rating Scale IV-Preschool Version as rated by parents or teachers. Using a randomized wait-list controlled experimental design, the investigators will explore the efficacy of practicing yoga for 6 weeks on behavioral symptoms, attentional control using a computer based tasks of attention, and heart rate variability (HRV), which is a measure of self-regulatory capacity. The investigators hypothesize that practicing yoga for six weeks of will improve ADHD and other behavioral symptoms based on parent and teacher rating scales, which will correlate with improvements in scores on the computer based task of attention as well as with improvements in HRV.

NCT ID: NCT02642068 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Neuropsychology, Neuroimage and Neurophysiology in Adults With ADHD

Start date: August 1, 2014
Phase:
Study type: Observational

We anticipate that drug-naïve ADHD probands, particularly those with DAT1 or SLC6A2 gene variants may have higher level of altered microstructural integrity of frontostriatal (FS), frontoparietal (FP), other hypothesized fiber tracts and decreased brain activity of FS, FP, and other circuits, deficits in ERP, and impaired EF, SA, IIA and VM than probands without DAT1 or SLC6A2 gene variants or adult neurotypical. The alterations in the structural and functional connectivity, neurophysiological and neuropsychological functioning would be observed in the unaffected siblings as compared to neurotypical. The unaffected siblings will be in the intermediate position between drug-naïve adult ADHD probands and neurotypical. The genetic dosage is anticipated to pose the strongest effects on the cortical thickness, brain volume, gyrification and microstructural property of white matter, followed by neurophysiology, functional connectivity, and neuropsychological function with the least effect. In terms of longitudinal follow-up part, we also anticipated despite increasing thinning of cortical thickness, microstructural integrity of several targets fiber tracts, and brain activity of target brain regions and improving performance in EF, SA, IIV, VM from childhood to late adolescence and young adulthood in the neurotypical group, the slopes of developmental trajectories of these neuroimaging and neuropsychological function are lower in the ADHD group.

NCT ID: NCT02638168 Terminated - Clinical trials for Attention Deficit Disorder With Hyperactivity

Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these children have moderate to severe impairments in sleep, further exacerbating their already impaired academic, emotional and social functioning. In children with ADHD, 34% of prescribed sleep medications are antipsychotics that can cause marked weight gain and metabolic changes; alternate medications have either been found to be ineffective, difficult to tolerate or are largely unstudied in youth. Delayed sleep onset is strongly correlated with active symptoms of ADHD and Oppositional Defiant Disorder (ODD), suggesting that better control of disruptive behaviors could improve sleep patterns and this application will assess if the extension of the therapeutic effects of CNS stimulants into the early evening improves sleep onset.

NCT ID: NCT02635035 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

Start date: November 2015
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day in adults with attention-deficit hyper-activity disorder and Sluggish Cognitive Tempo (ACT). Patients will be assigned either LDX/Placebo for 10 weeks with a two week placebo washout period.

NCT ID: NCT02623114 Recruiting - Clinical trials for Attention-deficit/Hyperactivity Disorder

Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers

Start date: May 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study was to identify genetic, brain morphologic, and environmental biomarkers that contribute to the pathophysiology of attention-deficit/hyperactivity disorder (ADHD).