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Hyperkinesis clinical trials

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NCT ID: NCT01431326 Completed - Hypertension Clinical Trials

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

PTN_POPS
Start date: November 2011
Phase:
Study type: Observational

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

NCT ID: NCT01431235 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders

Start date: August 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.

NCT ID: NCT01430767 Completed - Clinical trials for Major Depressive Disorder

Measuring Adherence to Medication for Depression and Attention-deficit Hyperactivity Disorder

Start date: September 2011
Phase: N/A
Study type: Observational

Poor adherence is a common reason for treatment failure in many fields of medicine, and likely affects common psychiatric treatments as well. Members of the present study team have used Medication Event Monitoring System (MEMS®) caps effectively to objectively monitor adherence in skin disease, and have shown that they provide a much more accurate measure of adherence behavior than self-reports, pill counts, or serum drug concentrations. The present study will use MEMS® caps to measure adherence in 10 patients with depression and 10 patients with attention-deficit hyperactivity disorder (ADHD) from a student clinic population. The aims will be to show the usefulness of MEMS® caps in measuring adherence to psychiatric treatment, and gather data on typical adherence rates for depression and ADHD patients on typical treatment regimens. The data obtained will be used to inform future studies that use an intervention to improve adherence behavior and ultimately disease outcomes.

NCT ID: NCT01415440 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD

Start date: August 2011
Phase: N/A
Study type: Interventional

The aim of this study is to examine the mechanisms by which stimulant medications reduce symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic Resonance Imaging (MRI), the investigators have found that the volumes of certain brain regions are reduced in patients with ADHD. The reduced volumes were much less pronounced if patients had been treated with stimulant medications, suggesting that stimulants may reduce the symptoms of ADHD by reversing these volume reductions. In a second and related study, the investigators found that in patients with ADHD, emotional processing was normalized when patients were taking stimulant medications. Both studies point to possible mechanisms by which stimulants are effective; however, a significant limitation of these findings is that they were derived from cross-sectional studies. In this current study, the investigators hope to replicate these treatment effects of stimulants in a prospective, controlled manner. The investigators plan to measure ADHD symptom severity in patients before and after 12-weeks of controlled treatment with either a stimulant medication or placebo while utilizing structural and functional MRI. Combining imaging with a randomized controlled trial will allow us to better assess the effects of stimulants on brain function and structure.

NCT ID: NCT01395160 Completed - Bipolar Disorder Clinical Trials

Female Experiences and Brain Activity

FEBA
Start date: July 2011
Phase: N/A
Study type: Observational

The Female Experiences and Brain Activity study will investigate how different groups of people process information in different ways. Using electro-physiological methods it will investigate differences in brain activity between women with ADHD, women with bipolar disorder and those without a psychiatric illness. It will also investigate the relationship between patterns of brain activity, mood and functioning.

NCT ID: NCT01393574 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties

Start date: June 2011
Phase: Phase 4
Study type: Interventional

The study hypothesis is that some children with Attention-Deficit-Hyperactivity-Disorder (ADHD) who also have sleep onset difficulties will improve with Melatonin treatment to an extent similar to that of stimulants treatment. In order to check this hypothesis children with a new ADHD diagnosis who also have sleep difficulties will be treated with either Melatonin or with stimulants (Methylphenidate) for one month. The main outcome will be improvement of the ADHD symptoms.

NCT ID: NCT01388530 Recruiting - Clinical trials for Attention-Deficit/Hyperactivity Disorder

Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

Start date: July 2011
Phase: Phase 0
Study type: Interventional

This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.

NCT ID: NCT01369459 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder

MIP
Start date: November 2011
Phase: Phase 1
Study type: Interventional

The goal of this project is to develop and test a brief protocol designed to systematically integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD) into behavioral treatment services for adolescent substance users with co-morbid ADHD in everyday care. Primary study aims will yield proof-of-concept data on MIP feasibility and fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services utilization, medication acceptance and compliance, and satisfaction with treatment services.

NCT ID: NCT01364662 Completed - Clinical trials for Impulsive Aggression Comorbid With ADHD

A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

Start date: June 2011
Phase: Phase 2
Study type: Interventional

This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.

NCT ID: NCT01363544 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Start date: June 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that has a severe impact on a child's life and society. The core symptoms are attention problems, hyperactivity and impulsivity. These symptoms are related to disruptions in neurocognitive functions (such as inhibition: the ability to stop behavior) and disruptions in cortical regulation (such as 'cortical underarousal' as measured with the electroencephalogram). To date, the only evidence-based treatment is pharmacological. Medication is not effective in 20-30% of the children with ADHD and it can have side effects. The lack of alternatives for medication is a severe problem for these children and society. Neurofeedback is becoming increasingly popular for treating ADHD. Neurofeedback is a training in which a person learns to alter its cortical regulation. Neurofeedback has been classified as 'probably effective' but its treatment effects need further empirical evidence. Non specific training effects, such as individual attention, may also contribute to treatment success. In this research project the investigators compare the efficacy of neurofeedback with exercise, a second non-pharmacological treatment, that may be comparable with neurofeedback in terms of non-specific effects. Exercise is also a promising treatment because of its positive effects on behavior, neurocognition in several patient groups. For these reasons, exercise deserves systematic research in ADHD. Furthermore, the investigators compare the efficacy of these two treatments with an optimal pharmacological treatment with methylphenidate (MPH). The main question is if neurofeedback and exercise are comparable in efficacy with MPH for treating ADHD. The primary outcome measure is behaviour (symptoms of ADHD). Secondary outcome measures include neurocognition and cortical regulation. This research project will give answer to the question if neurofeedback and exercise are as effective as MPH. Furthermore, it will give insight in how these interventions will give rise to improvements in behavior.