716 Clinical Trials for Various Conditions
This study will evaluate the feasibility of adapted ESDM-informed caregiver coaching in children with comorbid ASD and ADHD, who are between 36 and \<132 months of age. There will be no study provided medication treatment in this study. Children will either be on ADHD medication prescribed by their own personal provider or will not be taking any ADHD medication (this will be documented by the study). The provided behavioral treatment will be eight \~60-minute sessions in ESDM-informed caregiver coaching delivered remotely through telehealth, for 8 consecutive weeks. The behavioral treatment is provided to children through Early Start Denver Model (ESDM)-informed caregiver coaching strategies, implemented within the child's typical daily routine by the caregiver.
This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD.
We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.
To look at the cognitive effects of abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder. To examine the safety, effectiveness and tolerability of abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder.
The goal of this interventional study is to learn the effects that stimulant medication prescribed to ADHD individuals has in their performance of attentive tasks, as measured by images and data collected through neuroimaging (fMRI) while also implementing new motion-correcting software. The main questions it aims to answer are: 1. How do the use of stimulants affect brain activity and motion in fMRI research in ADHD studies? 2. Can neurofeedback, an attentive task using real-time brain activity, engage the same brain circuits as seen with stimulant medication in individuals with ADHD? Researchers will compare participant's brain activity from the completion of attentive tasks performed in the scanner while following their regular medication regimen and while abstaining to take medication. Researchers will also compare how the data collected using a more precise motion correction software differs to other previously reported data from ADHD studies who possibly employed more lenient measures of motion correction. Participants will: 1. Be asked to complete at least 4 fMRI sessions, two of which will include neurofeedback 2. Be asked to abstain from taking stimulant medication on the day of two of these fMRI visits 3. Complete attentive tasks while in the scanner that will activate target brain regions of interest
The purpose of this study is to better understand sleep and circadian functioning in children with ADHD using home-based measures, parent report, and a lab based melatonin assessment. Investigators will also examine how sleep relates to psychiatric health and cognition among children with ADHD. The investigator for this study is Dr. Jessica Lunsford-Avery from the Department of Psychiatry.
Teens with Attention-Deficit/Hyperactivity Disorder (ADHD) have high rates of negative driving outcomes, including motor vehicle crashes, which may be caused by visual inattention (i.e., looking away from the roadway to perform secondary tasks). Two versions of a driving intervention that trains teens to reduce instances of looking away from the roadway will be tested in teens with ADHD.
Impulsive Aggression and chronic irritability (IACI) often occur together and are one of the most common reasons children present for behavioral health (BH) care. ADHD frequently associated with IACI as upwards of 50% of youth with ADHD manifest impairing IACI levels. IACI is the most common reason that children with ADHD are prescribed antipsychotics and admitted to inpatient BH units. Systematic dose optimization of CNS stimulants improves levels of IACI, reducing the need for these more intensive and burdensome treatments. However, response varies, with over half of children with ADHD showing meaningful improvement, upwards of 40% receiving minimal benefit and 3 to 10% exhibiting increased IACI levels. Symptom levels of ADHD or IACI and other demographic variables are of limited utility for predicting response, suggesting the need to move beyond symptoms in the search for treatment predictors. Youth with ADHD and IACI struggle with multiple aspects reinforcement learning (RL), defined as learning from interactions with the environment to reach a goal. Successful RL efforts tap multiple cognitive functions. In controlled laboratory tasks, youth with IACI and various BH disorders exhibit excessive behavioral and neural response to receiving reward (reward responsiveness), difficulty processing environmental cues to adapt behavior to meet a goal (set shifting/goal updating) and impaired ability to flexibly attend to relevant stimuli when blocked from a goal (frustrative nonreward). Event related potentials (ERP) are small electrical responses in the brain in response to specific events or stimuli measured by electroencephalogram (EEG) testing. ERPs exist that can serve as established neural measures of each of these cognitive functions offering a child friendly means to assess their contribution to observable levels of IACI. CNS stimulants improve functioning in these specific realms and impact associated ERPs to the degree that differences between ADHD and non-ADHD youth disappear. This study will examine the capacity of these ERPs to predict levels of IACI exhibited by children with ADHD when at home. Investigators will then assess if variability across children in the capacity of CNS stimulants to impact RL associated ERPs accounts for differences in the clinical effects of CNS stimulant medications to improve IACI at home using a multimethod battery integrating ERPs, parent report and task performance. Specifically, investigators will examine variance in the reward positivity (RewP) ERP when receiving reward feedback, the switch positivity (SwP) ERP measuring mental effort when cued to shift set and the change in P3b amplitude measuring attention allocation when transitioning from reward to nonreward on a go-no-go task. To achieve these aims, 136 children with ADHD and elevated IACI levels will have their CNS stimulant dose optimized over six weeks and then complete a two week within subjects crossover trial of placebo versus optimal dose. ERP collection will be completed within each blinded week. Parent ratings will be gathered 3 times per day including during peak and off-peak times of medication efficacy to capture the variance in IACI levels within the day and disentangle reports of worsening IACI related to loss of previously beneficial medication effects versus those most likely related to a direct adverse response to medication.
Attention deficit/hyperactivity disorder (ADHD) can present differently in individuals, with some individuals having difficulty with attentional control, hyperactivity, impulsivity, emotion dysregulation, and/or neurobehavioral functioning. The factors contributing to these different presentations remain unclear, but altered patterns of physical activity, sleep, and circadian rest/activity rhythms may play a key role. The goal of this study is to leverage wearable technology (i.e., a wristband) to investigate the relationships between physical activity during the day, sleep patterns and disturbances, and 24-hour circadian rest/activity rhythms with differences in ADHD symptoms, emotion dysregulation, and related brain and behavioral features of attention-deficit/hyperactivity disorder (ADHD). The investigators hope this study will help improve assessment and intervention for individuals with ADHD by understanding how these factors relate to ADHD symptom expression and associated brain differences in ADHD. Participants taking stimulant medication must withhold stimulant medication 24 hours before their research appointment and the morning of their research appointment. Stimulant medication may be restarted after the appointment is complete. Participation in this study will require children to complete an initial 2-hour research appointment, two (2) weeks of activity and sleep monitoring at home using a wearable wristband and answering questions sent to a smartphone, and a second 4-hour research appointment after the 2-week period. During the first research appointment, children will complete a cognitive assessment and a practice magnetic resonance imaging (MRI) scan. Parents/legal guardians will participate in the 30-45-minute sleep device training session with one of the research staff. During the two weeks of activity/sleep monitoring at home, parents and children will answer questions about their sleep routine, ADHD symptoms, and emotional responding each morning and evening. Parents will be asked to install a questionnaire application on their smartphone. A prompt will be sent to their smartphone multiple times per day reminding parents to complete the brief assessment. After the 2-week period, children will complete a 4-hour research appointment. During this research appointment, children will complete a 60-minute MRI scan and computer-based activities that assess cognitive skills, reward-based decision-making, and frustration tolerance. At the end of the research appointment, children will return the device to our research team. Parents may delete the questionnaire application from their phone at the end of the research appointment. Participation will also require parents/legal guardians to complete questionnaires about their child. Questionnaires will be provided to the primary caregiver by email or at the beginning of their child's first research appointment. Parents agree to complete and return the questionnaires within one month of their child's research appointment. Parents may be provided with additional questionnaires to give to their child's primary schoolteacher. This information is collected to better understand children's abilities, behavior, strengths, and weaknesses. There are minimal risks associated with this study. Risks include fatigue, boredom, and mild discomfort. There is no cost to participating in this study. There is no direct benefit to participants for participating in this study.
To evaluate the efficacy and safety of NRCT-101SR compared to placebo in subjects 13-17 years of age with ADHD
Part II is a double-blind, randomized, parallel-group, placebo-controlled study. The primary objective of this trial is to determine the effective doses and treatment period of PDC-1421 Capsule in subjects with ADHD. The secondary objective is to evaluate the safety of PDC-1421 Capsule in subjects receiving PDC-1421 at various dose levels.
This open label, flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents (6 to 17 years of age) with Attention-Deficit/Hyperactivity Disorder (ADHD).
This study will evaluate the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) in adults 18-65 years of age with Attention-Deficit/Hyperactivity Disorder (ADHD).
Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.
The purpose of this study will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opportunity to receive 4-weeks active TNS treatment.
The purpose of this study was to evaluate the effect of 4-week SPN-810 treatment on brain functioning in patients aged 8-12 years with ADHD and associated feature of impulsive aggression (IA). This was achieved using functional magnetic resonance imaging (fMRI) in conjunction with the point subtraction aggression paradigm (PSAP) Task, a behavioral aggression paradigm in which subjects are provoked by having money indirectly taken from them by a fictitious opponent, simulating an aggression response.
The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with ADHD.
The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.
Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study were invited to participate in this study. This was a Phase 3 open-label extension (OLE) study to collect long-term safety data on the use of SPN-810 in treating impulsive aggression in pediatric subjects with ADHD when taken in conjunction with standard ADHD treatment. After confirmation of eligibility, all subjects were treated with SPN-810. Subjects were given a choice to extend participation in this study every 6 months for up to 36 months.
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.
This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of Impulsive Aggression (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 426 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.
To provide additional, required information on the pharmacokinetic profile of SHP465 in the targeted population (children and adolescents aged 6-17 years of age with ADHD).
This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD. The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments.
The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD). Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles, other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect profiles.
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed childhood disorders, with prevalence rates estimated at 8%. Several of the primary symptoms of ADHD relate to problems with temporal and materials organization (i.e. has difficulty organizing tasks and activities, loses things, is forgetful, and fails to finish school-work). In the school setting, problems with organization manifest as forgetting to complete or losing homework assignments, difficulties planning for the completion of long-term projects and studying for tests, and problems keeping class materials organized. These organizational difficulties become particularly problematic in middle school and are associated with low school grades and high parent and teacher ratings of academic impairment. In fact, organization of homework materials is one of the strongest predictors of academic performance in students with ADHD, above and beyond the impact of intelligence, school services, and ADHD medication use, and mediates the relationship between symptoms of ADHD and school grades. Given the relationship between temporal and materials organization and poor school performance, it is clear there is a need for interventions to address these difficulties. The PI sought to address this need by completing an IES Goal 2 study to develop a school-based intervention targeting organizational skills that was feasible for school mental health (SMH) providers to implement. The Homework, Organization and Planning Skills (HOPS) intervention was developed and refined based upon input from 20 school mental health (SMH) providers, students with ADHD and their families. SMH providers implemented the HOPS intervention, rated the intervention as highly user-friendly and feasible to implement, and demonstrated excellent fidelity to intervention procedures. Students who received the HOPS intervention made significant improvements in homework problems and organizational skills compared to a waitlist control. The feasibility and fidelity data demonstrate that the intervention has potential for widespread dissemination. Preliminary outcome data suggest that the intervention may significantly improve the academic performance of students with ADHD. However, the small sample size (N=23 HOPS \& N=24 control) precludes firm conclusions about efficacy and moderators and mediators of intervention response. Accordingly, the primary goal of this Goal 3 study is to evaluate the efficacy of the HOPS intervention, which focuses teaching students' organization and time-management skills, as compared to an intervention targeting on-task behaviors during homework completion and efficiency of work completion, the Homework Support Intervention (HSI), and to assess moderators and mediators of intervention response. Middle school students with ADHD (N=260) will be randomly assigned to receive the HOPS intervention or the HSI intervention. Students in both groups will receive the same amount of intervention in terms of duration and frequency of intervention sessions. Six cohorts of students will be recruited for the project. Each cohort will consist of 22 students at each of two schools (44 per cohort) who will be randomly assigned to each of the two conditions. Objective measures of skills implementation, parent and teacher ratings of organization, homework problems, and academic impairment, and school grades will be examined pre and post intervention as well as at 8-week and 6-month follow-ups. Treatment fidelity and integrity will be closely monitored. Moderator and mediator analyses will be used to answer important questions about the types of students most likely to benefit from organizational skills intervention and the key mechanisms of change that lead to improved academic performance. This study has significant potential to improve the academic performance of students with ADHD because the intervention was designed with SMH provider input and has clear potential for widespread dissemination upon proof of efficacy.
This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks. Patients who achieve a stable dose during the dose optimization period will continue participation and will be randomized to take double-blind medication (AR11 or placebo) orally twice daily for 1 week. At the end of each double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments.
This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with OROS-Methylphenidate (OROS-MPH, Concerta). The study aims to examine the effects of treatment with memantine on ADHD symptoms. Following screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks, along with open-label OROS-MPH (everyone receives medication).
The purpose of this study is to a) assess the efficacy of omega-3 fatty acids in the treatment of Deficient Emotional Self-Regulation (DESR) among stimulant treated Attention Deficit Hyperactivity Disorder (ADHD) adults, b) assess the side effect profile of omega-3 fatty acids in the treatment of DESR among stimulant treated ADHD adults, c) assess effects of omega-3 fatty acid supplementation on ADHD symptoms and associated features in stimulant treated ADHD adults, and d) predict value of fatty acids present in red blood cell membranes. This study will be a 12-week trial with adults 18-55 years of age with ADHD and symptoms of DESR.