Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301...
ADHDADHD - Combined Type5 moreThe goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in children (6-12) with ADHD in a laboratory classroom setting.
Attention and Pain in Children With and Without Attention Deficit and/or Hyperactivity Disorder...
Attention Deficit Disorder With HyperactivityPlacebo Effect2 moreIn Quebec, there has been an important increase of Attention Deficit Hyperactivity Disorder (ADHD) diagnosis since 2015. ADHD symptoms, related to behavioural and/or concentration difficulties, are very similar to other disorders symptoms, such as anxiety and depression, and have a significant impact on students' academic success and future life. Adults (parent, teacher, coach) expectations towards a child's abilities are consciously or unconsciously perceived by the child, influence his expectations of his own abilities, and thus his academic performance (Pygmalion effect). The child and his entourage's expectations are therefore a major factor to consider, especially in school-age children. According to ADHD studies, some brain areas involved in pain regulation and in attention cognitive abilities develop at a slower rate in children with ADHD than the other children. Considering the deleterious consequences generated by the symptoms of this disorder, the research project aims to better understand the role of expectations in children with ADHD in a medical (pain) and school (attention abilities) context. It also aims to contribute to better understand the role of the brain on the expectations effect and ADHD. In this study, children expectations will be modulated while pain experiments and cognitive task will be realized by children with and without ADHD. Brain measures will also be assessed with advanced techniques. Thus, we hope that the results will help improve intervention strategies in these contexts to ensure better support for children with ADHD, with a distant goal of contributing to the development of stronger tools for differential diagnostics.
HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre,...
HaloperidolAdvanced Cancer3 moreBackground and Clinical Need: Delirium is common at the end of life and is challenging to control. There is a clinical need to study the benefits of commonly used drugs like Haloperidol and Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients in a scientifically robust manner. Aims/Hypotheses: The investigators aim to study the effectiveness of Haloperidol compared with Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients receiving palliative care. The investigators hypothesise that Olanzapine is as effective as Haloperidol in the control of hyperactive delirium. Methods: The investigators will conduct a pragmatic, multi-centre, (hospital, inpatient hospice, community hospital) open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium. The primary outcome is the change in Richmond Agitation and Sedation Scale (RASS) scores among patients in each treatment group at 8 hours post-drug administration. The secondary outcome is the control of hyperactive delirium at 24, 48 and 72 hours using either Haloperidol or Olanzapine. The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications, survival after enrolment into study will also be studied. Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease. Haloperidol is used traditionally in palliative care for managing delirium. However, as a conventional anti-psychotic, it does cause extra-pyramidal side-effects. Olanzapine, a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium. These 2 commonly used drugs have never been compared head to head in a randomised-controlled, multi-centre study.
A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity...
Attention Deficit/Hyperactivity DisorderThe primary purpose of this trial is to evaluate the safety and tolerability of centanafadine QD XR in pediatric subjects with ADHD.
Melatonin in ADHD and Sleep Problems
Attention Deficit Hyperactivity DisorderSleep DisorderTreatment with melatonin is often initiated on an insufficient basis as it has not been established prior to starting the treatment whether or not the child had delayed release of endogenous melatonin. At the clinic, it has furthermore been observed that the length of time a child experiences an effect of melatonin treatment varies substantially. In a clinical context, treatment with melatonin is used increasingly (www.Medstat.dk). However, there is no tradition in Denmark for measuring the endogenous melatonin level before initiating such treatment. Hence there is no way of knowing to what extent the sleep problems were indeed caused by delayed melatonin release. There seem to be no studies on the difference in the effect of melatonin treatment of children and adolescents depending on whether or not they have delayed DLMO. Likewise, there are no studies including adolescents. As can be seen, it is important to gain more knowledge about the normal release of melatonin, and the release of melatonin in a group of children and adolescents with a variety of psychiatric diagnoses. It is also essential to investigate whether there are any differences in the release of melatonin in children and adolescents with chronic sleep onset problem and children and adolescents who do not have sleep problems.
A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)...
Attention Deficit Hyperactivity DisorderThe main aim of this study is learn more about long-term treatment of children and teenagers with ADHD for whom earlier stimulant therapy did not work. The study has two parts (A and B). In Part A, participants will take tablets of TAK-503, atomoxetine or placebo. Participants who take placebo tablets in Part A, will take TAK-503 tablets in Part B. Participants who take TAK-503 or atomoxetine tablets in Part A, will be treated with TAK-503 in Part B.
A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD
Attention Deficit/Hyperactivity DisorderThe 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.
The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)...
Attention Deficit/Hyperactivity Disorder Combined TypeADHD Predominantly Inattentive Type2 moreThe purpose of this study is to investigate the familial response to Methylphenidate treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects development.
Digital Therapy for Treating Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity DisorderThis study is designed to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD. Investigators will also evaluate the safety of digital therapy for intervention treatment of childhood attention deficit hyperactivity disorder.
Efficacy and Speed of Action of a Product to Control Gastric Hydration and Gastroesophageal Reflux...
Oesophageal RefluxGastric Reflux1 moreA Randomised, Placebo-Controlled Clinical Trial off the Efficacy and Rapidity of Action of a Product Containing Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric pH and Reduce Symptoms of Gastric Reflux and Hyperacidity.