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ADHD clinical trials

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NCT ID: NCT05710965 Completed - ADHD Clinical Trials

Assessing a Wearable Digital Therapy for Youth With ADHD

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate and compare three different investigational wearable digital interventions to determine if they are helpful for improving symptoms and functioning in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

NCT ID: NCT05700539 Recruiting - ADHD Clinical Trials

Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

Attention deficit hyperactivity disorder (ADHD) is a disorder characterized by lack of attention, hyperactivity, and impulsivity. It can have major impact on everyday life and result in negative consequences for one's personal, academic, and work situation. For individuals with symptoms of ADHD, increased levels of anxiety and depression are common, and an overall reduction of quality of life is often present. This study protocol describes a clinical trial of internet-based cognitive behavioral therapy (iCBT), using a randomized controlled study design, with the primary aim to increase quality of life, as well as to reduce symptoms of ADHD, anxiety, depression, and stress. A second aim is to investigate, by qualitative means, what aspects of treatment were perceived as helpful and hindering when it comes to completing iCBT. Two hundred participants with symptoms of ADHD will be included and randomized to two conditions (treatment and wait-list control). The treatment period is comprised of ten weeks, with two mandatory modules and ten modules from which the participants can choose freely. Self-report measures are completed by the participants at baseline and end of treatment, as well as at a six-month follow-up. The treatment is guided by therapists and consists of weekly correspondence with the participants. The study will utilize an intention to treat design, with ANOVAs and Reliable Change Index to evaluate treatment effects. The qualitative part of the project will be interview-based and employ thematic analysis. Lastly, a psychometric evaluation of a common instrument for determining ADHD-symptoms will also be made. The results will hopefully contribute to the evidence base for iCBT for individuals with symptoms of ADHD and help disseminate potentially effective interventions.

NCT ID: NCT05683249 Completed - ADHD Clinical Trials

Study to Evaluate NRCT-101SR in Adult Attention Deficit Hyperactivity Disorder (ADHD)

Start date: February 25, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of NRCT-101SR compared to placebo in adult patients with ADHD aged 18 years and older.

NCT ID: NCT05668195 Recruiting - ADHD Clinical Trials

Systematic Aerobics and Intelligent Monitoring System in Executive Skill Training for School-aged Children With ADHD

Start date: May 24, 2022
Phase: N/A
Study type: Interventional

Around 7.2% of children around the world are suffering from Attention Deficit Hyperactivity Disorder (ADHD). Systematic executive skill training for children is currently recognized as one of the main programs for psychosocial behavioral interventions in ADHD, but the theoretical basis for the 1 hour "play class" component of the 3 hours per week children's classroom is insufficient. We have developed a closed-loop moderate-intensity aerobic training system, which is combined with an intelligent monitoring system, to further standardize and improve the treatment and management of ADHD intervention. The intelligent monitoring system in this study includes physiological intelligent monitoring (heart rate data) and psychological and behavioral intelligent monitoring (based on the computerized "adaptive" executive function testing procedures and clinical questionnaire scale). 200 subjects aged 6-12 years with a diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria are randomly assigned into two groups to receive executive skill training and systematic aerobic exercise and intelligent monitoring system, or systematic executive skill training for 13 weeks. Symptoms severity is assessed by Vanderbilt Assessment Scales at weeks 0, 6, and 13. Subjects' executive function is assessed using executive function tests before and after training, parental depression/anxiety assessment, family environment assessment, and monitoring of heart rate during exercise are also included. All the other sociodemographic data are assessed. This study will investigate the effects of systematic aerobic exercise and intelligent monitoring system in executive skill training on the promotion of cold executive functions such as responsiveness, flexibility, and inhibition and hot executive functions such as reward mechanisms in children, and their effects on children with ADHD and their families.

NCT ID: NCT05664698 Recruiting - ADHD Clinical Trials

Emotion Regulation Training for Adolescents With ADHD

Start date: January 24, 2023
Phase: N/A
Study type: Interventional

The goal of this single-case study is to pilot and evaluate a new psychological intervention (SKILLS-ER) targeting emotion regulation in adolescents with ADHD. Participants (n=9; 13-18 years of age) and their parents will partake in the intervention consisting of a total of eight sessions.

NCT ID: NCT05650775 Recruiting - ADHD Clinical Trials

Biomarkers of ADHD Treatment Response

BAT
Start date: February 17, 2023
Phase: Phase 1
Study type: Interventional

The goal of this translational biomarker study is to use electroencephalography (EEG) to identify brain signatures that will predict a child's response to two of the most commonly prescribed ADHD medications, methylphenidate and mixed amphetamine salts. The main questions the investigators aim to answer are: 1. Do children with ADHD who show symptom reduction with methylphenidate have different EEG profiles than children who do not respond well to methylphenidate? 2. Do children who respond better to mixed amphetamine salts than to methylphenidate have unique EEG profiles? The investigators will measure brain activity before the participating children have tried any stimulant medications, and then again after a 3-week trial of Concerta (methylphenidate). Participants who do not show significant symptom improvement on Concerta will then complete a 3-week trial of Adderall (mixed amphetamine salts), and the study will measure brain activity while those children are on the best dose of Adderall. The investigators will collect information from the child, caregivers, and teachers each week to measure ADHD symptom improvement and side effects. This study will therefore follow the typical treatment approach used in the Boston Children's Hospital Developmental Medicine Clinic, but the investigators will add measures of brain functioning before and after medication.

NCT ID: NCT05635318 Not yet recruiting - ADHD Clinical Trials

Quantitative EEG Neurofeedback as an Add-on Therapy For Attention-deficit Hyperactivity Disorder (ADHD)

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Attention deficit/hyperactivity disorder (ADHD) is a common neurological disorder in children, mainly manifesting as attention deficit, excessive hyperactivity, and impulsivity. It is a chronic condition that affects millions of children and often continues into adulthood. The prevalence of ADHD in the worldwide is approximately 5%, predominantly occurring in boys, and more than half of patients continue to experience symptoms into adulthood. Children with ADHD have moral disorders and learning difficulties, and these factors will seriously affect their academic achievements and familial and social relationships; thus, treatment is necessary. Currently, the treatment for ADHD is usually pharmacological intervention, such as methylphenidate, Atomoxetine…. etc. However, research has suggested that pharmacological intervention has side effects on nervous system development in children, and the long-term efficacy is uncertain. In recent years, the efficacy of neurofeedback (NF) therapy, as a type of biofeedback method, has been proven in many diseases, such as mild cognitive impairment, epilepsy, and autism, depression, and anxiety. NF converts signals such as EEG into visual or auditory information, and then subjects selectively enhance or inhibit certain components through training. There are three common NF protocols for ADHD: theta/beta training, sensorimotor rhythm (SMR) training, and slow cortical potentials (SCP) training. This study adopts the theta/beta NF protocol. As a promising nonpharmacological alternative treatment for ADHD, the efficacy of NF has been proven in many studies. The use of quantitative EEG neurofeedback as an add-on therapy can be markedly beneficial to shorten the period of pharmacological treatment and with minimal side effects.

NCT ID: NCT05631626 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.

Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in adults with ADHD in a laboratory classroom setting.

NCT ID: NCT05588505 Recruiting - ADHD Clinical Trials

Cognitive-Behavioral Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in College Students - Study 1

ADHD
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

College students with ADHD have significant difficulty effectively managing their time, organizing, planning, and completing their academic work. As a result, they typically have lower grade-point averages, more course failures and withdrawals, are more likely to be placed on academic probation and are less likely to graduate from college than students without ADHD. The purpose of this project is to refine and test a psychological intervention on campus to help students with ADHD develop these self-management skills so that they can be more successful in college and avoid these negative outcomes.

NCT ID: NCT05584475 Completed - ADHD Clinical Trials

Mindful Awareness Practices for ADHD Pilot Open Trial

Start date: October 5, 2022
Phase: N/A
Study type: Interventional

It is estimated that 25-40% of youth with ADHD have co-occurring cognitive disengagement syndrome (CDS; previously sluggish cognitive tempo), a set of behavioral symptoms characterized by excessive daydreaming, slowed thinking, and mental confusion and fogginess. A growing body of research demonstrates CDS to be associated with functional impairment above and beyond that which can be accounted for by ADHD severity. However, no treatment currently exists that directly targets CDS symptoms. This is a critical clinical and scientific gap, leaving youth with ADHD and co-occurring CDS at risk for experiencing negative immediate and long-term outcomes. In considering intervention approaches, mindfulness meditation involves regular practice to catch oneself when the mind wanders, and may thus an ideal intervention for youth with CDS. However, mindfulness interventions, including the Mindful Awareness Practices (MAPs) for ADHD, have never been tested in adolescents with ADHD and co-occurring CDS specifically. This study will recruit up to 15 adolescents with ADHD and co-occurring CDS symptoms to enroll in an open trial of MAPs to evaluate its feasibility, acceptability, and preliminary efficacy. Findings will provide key pilot data regarding treatment of CDS in adolescents with ADHD.