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Hyperkinesis clinical trials

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NCT ID: NCT05741307 Recruiting - Clinical trials for Attention Deficit/Hyperactivity Disorder

Effect of a Self-hypnosis on Attention Disorders and Anxiety in Children With Attention Deficit/Hyperactivity Disorder

HYPNAAX
Start date: September 4, 2023
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT05721235 Recruiting - Clinical trials for Attention Deficit/Hyperactivity Disorder

A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD

KP415P02
Start date: May 24, 2023
Phase: Phase 4
Study type: Interventional

The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.

NCT ID: NCT05718427 Recruiting - Clinical trials for Attention Deficit Disorder With Hyperactivity

Effect of ASI on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With ADHD

ASI-ADHD
Start date: March 29, 2023
Phase: N/A
Study type: Interventional

Attention Deficit Hyperactivity Disorder (ADHD) is a very common neurodevelopmental disorder in childhood characterized by short attention span, impulsivity and hyperactivity. It is also known that sensory integration problems are seen together with the basic symptoms of ADHD. Studies indicate that children with ADHD have difficulties in perceiving and processing sensory stimuli, and in relation to this, they have difficulty in producing appropriate sensory responses at school, at home and in social environments. However, it was observed that the interventions related to ADHD did not focus on the sensory-motor dimension enough, and focused more on cognitive or social skills. Although current research indicates the presence of sensory integration disorder in children with ADHD, there are no studies showing the effectiveness of sensory integration intervention. Our study was planned to examine the effect of Ayres Sensory Integration intervention on sensory-motor, cognitive, behavioral skills and social participation in children with ADHD. Materials and Methods: After the evaluation, 90 children with ADHD will be included in the study by dividing them into intervention (n=45) and control (n=45) groups by simple randomization method. Ayres Sensory Integration Therapy intervention will be applied to the intervention group for 10 weeks, 3 times a week, with a session duration of 1 hour, while the control group will continue the drug treatment and after a waiting period of 10 weeks, Ayres Sensory Integration Therapy will be applied after the second evaluation. Participants, Sensory Profile (SP), Sensory Integration and Praxis Test (SIPT), Emotion Regulation Checklist (ERC), Stroop Test TBAG Form (Stroop TBAG), Childhood Executive Functions Inventory (CHEXI), Participation and Environment Scale for Children and Adolescents (PEM-CY), Conners Teacher Rating Scale (CTRS), Conners Parent Rating Scale (CPRS), Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) and Goal Achievement Scale (GAS) both before and before intervention. and post-group change as well as between-group differences will be evaluated.

NCT ID: NCT05690698 Completed - Clinical trials for Hyperactive Delirium

Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Start date: April 9, 2023
Phase: Phase 3
Study type: Interventional

In population of intensive care unit (ICU), most studies compared atypical antipsychotics such as quetiapine with the traditional haloperidol in delirious patients of various forms and etiologies. The role of such agents in patients with hyperactive is not fully understood. This study compares the effectiveness of quetiapine with haloperidol in treating the hyperactive form of delirium in terms of their effects on morbidity, length of stay in the intensive care unit, and mortality in critically ill patients.

NCT ID: NCT05685732 Active, not recruiting - Clinical trials for Attention Deficit/Hyperactivity Disorder

An Efficacy and Safety Study w/ Azstarys® in Children With ADHD

KP415P01
Start date: March 22, 2023
Phase: Phase 4
Study type: Interventional

This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate.

NCT ID: NCT05683756 Recruiting - Sleep Clinical Trials

A Sleep Focused Parenting Intervention for Preschool Aged Children at Risk for ADHD

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

The goal of this pilot clinical effectiveness trial is to compare a brief parent behavioral intervention (PBI) to a modified sleep focused PBI (SF-PBI) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early ADHD symptoms. The main aims are to: - Demonstrate acceptability, feasibility, and appropriateness of the SF-PBI. - Examine change in sleep and ADHD symptoms among preschoolers with ADHD symptoms receiving SF-PBI compared to the brief PBI.

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: NCT05621174 Recruiting - Clinical trials for Attention Deficit Disorder With Hyperactivity

The Difference in the Mechanism of Action Between Two Brands of Dexamfetamine in Adults With ADHD

DAVE
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare in the pk/pd profiles of magisterial dexamfetamine and Tentin in adults with Attention Deficit Hyperactivity Disorder (ADHD). The main question[s] it aims to answer are: Q1: is there a difference between pk/pd profiles of the two forms of dexamfetamine? Q2: how does the pharmacokinetic variability influences the objective and subjective (side) effects experienced by adult patients with ADHD? Participants will: - take the Quantified behavior Test for analysis of objective effects. - undergo blood sampling for analysis of the plasma concentration of dexamphetamine. - undergo blood pressure and heart rate measurements. - fill out 4 types of questionnaires. Researchers will compare the outcomes between magisterial dexamphetamine and Tentin use in a crossover setting.

NCT ID: NCT05608434 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial

Start date: March 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions. This can affect their education, friendships, and daily life. Virtual reality-based games may help improve cognitive skills in children with ADHD. It may also help change how the brain functions. Objective: To see if virtual reality-based games help improve thinking skills and brain function in children with ADHD. Eligibility: Children aged 10 to 16 years with ADHD. Design: We will first do a pilot study, meaning that everyone will receive the games. If this is successful, we will then conduct a randomized controlled trial, meaning that some participants will be randomly assigned to the full version of the games and some will be randomly assigned to a limited version. Participants will be screened. Their physical and mental health, medical and family history, and intellectual and emotional development will be evaluated. They will have tests of their mood, memory, attention, thinking, and behavior. Blood or saliva may be collected. Participants may have an MRI scan of the brain. Participants will receive a set of virtual reality games. The set includes 4 different games all played using a virtual reality headset. The participant will play the games for 20 minutes 5 days a week for 4 weeks. The parent or caregiver will start each game using an iPad. Each of the games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, temporal information processing, and working memory. Participants will have interviews each week. They will answer questions about motion sickness, eye strain, headache, and any other side effects, as well as number of game sessions played. Blood or saliva tests and the MRI may be repeated after the last game session. For the pilot, participants will have a final interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.

NCT ID: NCT05592119 Recruiting - Clinical trials for Attention Deficit/Hyperactivity Disorder

Effect of Stimulant Medication on Loss of Control Eating in Youth With Attention Deficit/Hyperactivity Disorder

Start date: January 11, 2023
Phase:
Study type: Observational

Loss of control eating (LOC-E) in youth predicts the later development of full syndrome eating disorders, such as binge-eating disorder (BED), and therefore, could be a relevant target for prevention interventions. Children with attention deficit/hyperactivity disorder (ADHD) are at higher risk of experiencing LOC-E than healthy controls, and there is evidence that related neurocognitive predisposing factors, such as impulsivity and dysfunctional reward processing, are associated with the pathogenesis of LOC-E. Therefore, it is pertinent to examine whether modifying these neurocognitive symptoms influences LOC-E and the subsequent development of eating disorders. Stimulants are an efficacious treatment for impulsivity in youth with ADHD and have been shown to improve symptoms of binge eating in adults; however, studies have not prospectively explored the effect of stimulants on LOC-E in youth. To explore this gap, the investigators aim to collect prospective observational data in a clinical setting to measure change in LOC-E episodes and secondary outcomes in youth aged 8 to 13 years old with ADHD and LOC-E who are treated with stimulants. The investigators will collect outcome measures prior to stimulant initiation (baseline) and 3 months after stimulant initiation.