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Hyperkinesis clinical trials

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NCT ID: NCT02466386 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder

Start date: August 21, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).

NCT ID: NCT02457819 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Dasotraline Pediatric Extension Study

Start date: June 30, 2015
Phase: Phase 3
Study type: Interventional

This is an open label 26 week extension study for subjects who completed SEP360-202.

NCT ID: NCT02430896 Recruiting - Clinical trials for Attention Deficit Disorder With Hyperactivity

Identification of Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of ADHD

Start date: February 2015
Phase:
Study type: Observational

The objective of this study is to identification of neuropsychological, genetic and neuroimaging markers and treatment response predictors of attention-deficit/hyperactivity disorder (ADHD). Participants who take the standardized pharmacotherapy (methylphenidate or atomoxetine) for ADHD will be observed for 52 weeks. They will do several neuropsychological, neuroimaging and genetic tests at visit 1~6.

NCT ID: NCT02428088 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Dasotraline Pediatric ADHD Study

Start date: April 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.

NCT ID: NCT02407496 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Neurophysiological Attention Test (NAT) for Objective Assessment of Attention Deficit Hyperactivity Disorder (ADHD)

NAT-I
Start date: June 2014
Phase:
Study type: Observational

The purpose of this study is develop a new assessment tool for Attention Deficit-Hyperactivity Disorder (ADHD) and to then test its validity (i.e. ability to discriminate between individuals with ADHD and healthy controls).

NCT ID: NCT02402166 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder

Start date: April 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD population.

NCT ID: NCT02392169 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Neuroendocrine Substrates, Candidate Genes and Endophenotypes in ADHD

Start date: August 2013
Phase: N/A
Study type: Observational

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common child and adolescent psychiatric disorders. In recent years, some researchers have become interested in analyzing neuroendocrine substrate levels in ADHD, including dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), cortisol and testosterone. Previous work in ADHD has established a strong heritable component to the phenotype. The STS gene, SULT2A1 gene and TH gene are associated with the function of DHEA/DHEA-S, and the NR3C1 gene is associated with the regulation of cortisol. Therefore, the relationship between these genes and the etiology of ADHD warrants investigation. Moreover, compared to the phenotype, the endophenotypes of ADHD may be more capable of detecting the underlying neurobiological and hereditary mechanisms. Therefore, this study aims to investigate the relationships between neuroendocrine substrates (DHEA, DHEA-S, cortisol and testosterone), candidate genes (STS gene, SULT2A1 gene, TH gene and NR3C1 gene) and the phenotype and endophenotypes (disease subtypes, neurocognitive function and response to treatment) of ADHD. To complete this work, we will recruit 300 patients with ADHD (probands) and 600 biological parents of the probands. DNA will be extracted from buccal cells by cheek swab. At baseline, saliva samples of ADHD patients will be collected between 7:00 and 8:00 am using the passive drool method, to analyze the levels of neuroendocrine substrates. The patients will undergo assessment for their clinical symptoms and neurocognitive function. Methylphenidate will then be administered to the patients and the usual practice followed. At week 4 and week 52, procedures similar to those performed at baseline will be repeated. The results of this study may further elucidate the complexity of the pathophysiology of ADHD. We may determine whether the neuroendocrine system, which contains levels of neuroendocrine substrates and associated genes, plays a crucial role in the phenotype and endophenotypes of ADHD. The information may serve as an important reference for the direction of future study and clinical treatment for patients with ADHD.

NCT ID: NCT02364817 Recruiting - Alcoholism Clinical Trials

ADHD: Gaps Between Patients With Alcohol-dependence and Impact on Relapse

AGADIR
Start date: January 2015
Phase:
Study type: Observational

Some recent studies have found that adult attention deficit - hyperactivity disorder (ADHD) was frequent among patients with alcohol-dependence. However, no investigation has ever addressed whether ADHD may impact the drinking outcome. Moreover, most of the different aforementioned studies assessed ADHD using the ADHD self-report scale (ASRS). The ASRS is a screening questionnaire that is of limited diagnostic value, and the overrepresentation of high-score ASRS among patients with alcohol-dependence could be in part due to differential diagnoses such as antisocial or borderline personality disorders, executive function impairments, or isolated impulsiveness. The study aims to evaluate "ADHD: Gaps between patients with Alcohol Dependence and Impact on early Relapse" (AGADIR). In AGADIR, subjects with alcohol-dependence are recruited at the end of a residential detoxification program. They are assessed for ADHD using the ASRS, but also with a standardized diagnostic tool, i.e., the Diagnostic Interview for ADHD in adults (DIVA 2.0). Potential differential diagnoses are screened during the baseline visit. The patients are followed-up during the 12 first post-detox weeks, through a standardized psychosocial treatment. ASRS is re-performed at the end of the follow-up.

NCT ID: NCT02358941 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Neurofeedback and Computerized Cognitive Training in Different Settings for Children and Adolescents With ADHD

Start date: December 2013
Phase: N/A
Study type: Interventional

Attention deficit/hyperactivity disorder (ADHD) is among the most common childhood-onset psychiatric disorders, with a negative and long-lasting impact on academic achievement, social integration and quality of life. In recent years, the efficacy of non-pharmacological treatments for ADHD, such as neurofeedback training (NF) and computerized cognitive training (CCT), has been at the centre of research. Although an increasing number of well-designed studies have shown that both methods may improve ADHD core symptoms according to parents' ratings, the underlying mechanisms are still a matter of debate. Teachers often report smaller improvements, if any. This has been explained by their lesser involvement in the training. It remains questionable, however, whether other factors may also account for this effect and whether methods other than placebo control may be applied in order to demonstrate the specificity and efficacy of NF and CCT. The main purpose of this project is to demonstrate and compare the efficacy of two different computer-based treatment methods for children and adolescents with ADHD, namely NF and CCT, and to examine the impact of different treatment settings, with half of the participants being trained in a clinical setting and the other half at school. The investigators want to show that is feasible to implement NF and CCT in a school setting and that both methods, conducted either at school or in a clinical setting, may lead to significant improvements of ADHD symptoms as well as to specific and differential effects. Besides the differential impact of the settings on informant ratings, the investigators will evaluate the effects of the training methods on neuropsychological and electrophysiological outcome. Classroom behavior of the children before and after the training will be evaluated by trained observers not informed on treatment assignments and settings.

NCT ID: NCT02343575 Terminated - Clinical trials for Hyperactive Delirium

Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU

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

Delirium is the most often encountered psychiatric diagnosis in the general hospital, with incidence up to 85% in the intensive care unit (ICU) setting and with significant consequences on patients' morbidity and mortality. Currently, although not FDA approved, antipsychotics are often considered the first-line pharmacological treatment. However, there can be limitations to their use, including side effects or lack of efficacy. Valproic acid (VPA) is one of the alternatives at times used in such patients which from limited case series data appears to be helpful and tolerated. VPA can provide relief from agitation that poses a threat to the safety and recovery of the patient. Moreover, mechanistically it addresses the neurochemical and cellular abnormalities inherent in delirium (it has NMDA-antagonist, anti-dopaminergic, GABAergic,anti-inflammatory, anti-apoptotic, and histone deacetylase inhibitor properties, among others). The purpose of this study is to evaluate the efficacy and tolerability of the VPA in the first known to us randomized controlled trial.