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ADHD clinical trials

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NCT ID: NCT03333668 Active, not recruiting - ADHD Clinical Trials

Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents

AGUALIS
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This is not a clinical trial. The aim of this study is to understand the mechanism of action of two recently licensed drugs for ADHD on brain function. We will compare the brain activation changes elicited by Guanfacine extended release (GXR; a non-stimulant drug) with the brain activation changes elicited by Lisdexamfetamine (LISDEX; a stimulant drug) and by placebo in 20 drug-free patients with ADHD using functional Magnetic Resonance Imaging (fMRI). For this purpose we intend to scan participants during their performance of tasks of attention, working memory, and inhibition, which we know from previous studies to elicit abnormal brain activation patterns in ADHD patients (Rubia et al., 2005; Smith et al., 2006).

NCT ID: NCT03324464 Recruiting - ADHD Clinical Trials

Central Executive Training (CET) for ADHD

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The goal of the current project is to assess the efficacy of Central Executive Training (CET) for youth with ADHD. CET is a new, computerized training intervention that targets specific components of the working memory system. Two versions of CET were developed as part of our R34, each targeting a different combinations of executive functions. The final CET protocol reflects the contributions and feedback of a diverse group of caregivers, children with ADHD, and recognized experts in human cognition, ADHD treatment research, randomized control trial (RCT) intervention design methods, serious game theory and task design, cognitive training, and the role of executive dysfunction in ADHD.

NCT ID: NCT03292952 Completed - ADHD Clinical Trials

KP415 Classroom Study in Children (6-12 Years of Age) With ADHD

Start date: December 20, 2017
Phase: Phase 3
Study type: Interventional

The study is a multicenter, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy laboratory classroom study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).

NCT ID: NCT03292848 Completed - ADHD Clinical Trials

Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders

Start date: October 10, 2017
Phase: Phase 1
Study type: Interventional

A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders.

NCT ID: NCT03279952 Recruiting - ADHD Clinical Trials

Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

There has been an increasing focus on the adverse impacts of irritability, defined as increased tendency towards anger. Irritability worsens peer relationships, family functioning, academic performance and is a risk factor for depression, suicide and substance use and is one of the main reasons why children get referred for treatment. It has been identified as transdiagnostic entity meriting investigation as a treatment target for personalized intervention given its prevalence and morbidity. Most children with prominent irritability also meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) but only a subset of children with ADHD manifest impairing levels of irritability. Irritability levels are only minimally correlated with severity of ADHD symptoms suggesting that irritability is not simply a manifestation of severe ADHD. The first line treatment for irritability in children with ADHD is to optimize the dose of the CNS stimulant. However, there is great heterogeneity in response, with baseline mood lability being the best marker for both improving and worsening irritability. In addition, increased irritability is one of the most common reasons why parents stop these medications. The unpredictability in response to CNS stimulants has led to the increasing use of antipsychotics and other non-evidence based treatments for ADHD. It is unknown what drives this heterogeneity in response in part because little is known about the underlying causal mechanisms for irritability in youth with ADHD. Two areas theorized to contribute to irritability include impairments in learning from experience (instrumental learning) and sensitivity to reward and loss.1 There are objective methods for measuring these domains in children through the use of even-related potentials (ERPs)- synchronous neural activity in response to a stimulus. Reward positivity (RewP) is an ERP component occurring in response to feedback on task performance that can be broken down to separate reward and loss components. Irritability is thought to arise due to the combination of an enhanced drive for reward coupled with an excessive response to loss. No prior work has examined associations of RewP with irritability in ADHD. However, abnormalities in RewP and elevated irritability have both been established as risk factors for depression, suggesting that RewP may also predict irritability. Error related negativity (ERN) reflects the preconscious detection of potential conflict serving as an early warning signal for errors. Error detection is one of the first steps for instrumental learning. It is impaired in some youth with ADHD, with a suppressed ERN correlated with reduced error processing. CNS stimulants improve ERN amplitude and impaired error processing. We theorize that abnormalities in RewP and ERN in children with ADHD will serve as respective markers for severity of irritability and subsequent treatment response to CNS stimulants. If successful, we will have identified a causal pathway for irritability that will aide treatment development and identified a reliable biomarker for the current first line treatment for irritability in ADHD (CNS Stimulants), while providing care to a significantly impaired group of local children for whom few evidence-based treatments exist.

NCT ID: NCT03263156 Recruiting - Insomnia Clinical Trials

A Brief Parent-based Sleep Intervention for ADHD Children

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%, and often pose significant challenges and stress to the families. Sleep problems in ADHD children are strongly associated with the exacerbation of daytime symptoms, impaired physical health, and poor parental mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ADHD (aged 6-12). Eligible participants will be randomised to either intervention (two face-to-face consultation sessions and one follow-up phone call) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), one-week after the intervention (post-treatment), and 3 months after the intervention.

NCT ID: NCT03247556 Completed - ADHD Clinical Trials

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD

Start date: November 20, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents (12-17 years old) with ADHD

NCT ID: NCT03247543 Completed - ADHD Clinical Trials

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Children With ADHD

Start date: October 31, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of high doses of SPN 812 in children with ADHD

NCT ID: NCT03247530 Completed - ADHD Clinical Trials

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHD

Start date: October 20, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of low doses of SPN-812 in children 6-11 years of age diagnosed with ADHD.

NCT ID: NCT03247517 Completed - ADHD Clinical Trials

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHD

Start date: November 2, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of low doses of SPN-812 in adolescents 12-17 years of age.