Mazindol in Children With ADHD : Open-label, Efficacy, Safety and Pharmacokinetic Pilot Trial
Attention Deficit Hyperactivity DisorderThis prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.
Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)
Attention Deficit Disorder With HyperactivityThe survey is designed to identify non-compliant Attention Deficit Hyperactivity Disorder (ADHD) patients who are currently on Immediate- Released Methylphenidate (IR-MPH) and observe any change in compliance after treating with other drugs intended to treat ADHD for over 3 weeks
Genetic Measurements in Blood Cells of Children Taking Adderall or Methylphenidate
Attention Deficit Hyperactivity DisorderADHDThis study, conducted at Duke University in Durham, NC, will determine whether the drugs Adderall and methylphenidate affect the genetic material of children with attention deficit hyperactivity disorder (ADHD). One small study has shown that taking methylphenidate for ADHD may result in higher levels of certain types of changes to the genetic material contained in white blood cells. The changes seen are not directly linked to increased risk of disease, but indicate a possibility that other kinds of damage that may be linked to increased disease may result from taking methylphenidate. The study will also examine whether these types of changes might occur in children treated with Adderall . Children between the ages of 6 and 12 with symptoms of ADHD may be eligible for this study. Candidates are screened with a medical history, psychiatric examination, IQ test, physical examination, and electrocardiogram. Parents and teachers complete questionnaires to rate the severity of the child's ADHD. Qualified children who are diagnosed with ADHD and who are appropriate candidates for treatment with either Adderall or methylphenidate-based drugs (e.g., Concerta, Metadate, Focalin, Ritalin or Ritalin LA) may be selected for this study. At a baseline visit (Visit 0), parents complete questionnaires that rate the severity of their child's ADHD. The children have their vital signs checked (pulse, blood pressure, breathing rate, height, weight and temperature) and have a blood sample drawn. The children are then randomly assigned to treatment with either Adderall or a methylphenidate product. After the baseline visit, participants undergo the following tests and procedures: Dose Optimization Visits (visits 1-4) In the first 4 weeks of the study, the dose of methylphenidate or Adderall is adjusted weekly until doctors determine the dose strength that works best for the individual child. In addition, the following procedures are done at each visit: Child's vital signs are checked. Parents complete a questionnaire about the severity of the child's ADHD. Parent and child describe the impact of symptoms on the child's functioning. Parents complete forms about common side effects of the study drug. Follow-up Visits (visits 5-6) Children return to the clinic once a month to assess their health and further adjust their medication dose, if needed. The visits are similar to those during the dose optimization period, with the following additional procedures at visit 6: A blood sample is obtained to measure whether the medication has affected the child's genetic material. A physical examination is done to check child's health. Information is provided parents to assist in planning for child's treatment after the study.
Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension...
Pelvic Floor Muscle SpasmPelvic floor tension myalgia (PFTM) is increasingly noted in patients with chronic pelvic pain. Pelvic floor physical therapy is typically utilized and is at times combined with other therapies such as botox injections, trigger point injections or pudendal blocks. The investigators' study will randomize newly diagnosed patients with PFTM to weekly . Final patient assessment will be performed at 6 months to assess durability of response. Primary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy will result in lower pain and pelvic floor muscle tension scores, lower baseline vaginal pressure and increase pelvic floor strength. Secondary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy will result in a lower pain score in a shorter time frame, resulting in faster progress through physical therapy.
Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention...
Attention Deficit Hyperactivity DisorderThe study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.
Study of Attention Deficit/Hyperactivity Disorder Using Transcranial Magnetic Stimulation
Attention Deficit Disorder With HyperactivityAttention deficit/hyperactivity disorder is a condition characterized by a decreased attention span, hyperactivity, and/or impulsiveness inappropriate for a certain age. Typically, young children have what are known as subtle neurological signs. These are involuntary movements of one part of the body that occur while the child is making a voluntary movement of another part of the body. This is referred to as synkinesis, or overflow movements. These overflow movements disappear during normal development and are usually gone by the age of 10. However, in children with ADHD these overflow movements tend to be more intense and last long after the age of 10. This leads researchers to believe there is an abnormality in the maturation and development of the brain areas associated with motor activity in children with ADHD. Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that gives information about brain function. It is very useful when studying areas of the nervous system related to motor activity (motor cortex, corticospinal tract, and corpus callosum). A magnetic signal given from a special instrument held close to the patient's head stimulates a small area of the brain that controls a few muscles (for example, the muscles that control one finger). Doctors put electrodes (small pieces of metal taped to areas of the body) over the muscle to measure the electrical activity the muscle produces when it makes a movement. When the magnetic signal activates those muscles the electrodes pick up and record the electrical activity of the movement that the muscles make in response to the magnetic signal. Researchers will study normal children and those diagnosed with ADHD using TMS to find out if the clinical abnormalities of ADHD are associated with a delay or abnormality in maturation of areas of the nervous system responsible for motor activity (motor cortex and corticospinal tract).
A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment...
Attention-deficit Hyperactivity DisorderThe purpose of this observational study is to explore the efficacy of methylphenidate hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-scheduled for affective disorders (SADS)-present and life time version (K-SADS-PL).
Emotional Information Processing in Attention Deficit Disorder With or Without Hyperactivity
Attention Deficit Disorder With HyperactivityAttention Deficit Disorder Without HyperactivityThe aim of this study is to analyse explicit and implicit emotional information processing abilities in children with attention deficit disorder with or without hyperactivity
Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD
Attention Deficit Hyperactivity DisorderAttention Deficit Disorder1 moreThe aims of this study are to evaluate auditory sensitivity in teenagers with ADHD using acoustic reflex thresholds (ART) and to examine the effects of ADHD stimulant medication on ART.
Epigenetics in ADHD
microRNAs in Attention-deficit/Hyperactivity DisorderAttention-deficit/hyperactivity disorder (ADHD) is among the most common psychiatric disorders in children and adolescents. ADHD's nosology is largely based on clinical phenomenology that includes such symptoms as inattention, hyperactivity and impulsivity. However, a reliable ADHD biomarker has still not been determined either for differential diagnosis or for monitoring treatment effects. MicroRNAs (miRNAs) are small non-coding RNA molecules that function in the process of RNA silencing and the post-transcriptional regulation of gene expression. MiRNAs are found in abundance throughout the nervous system and play a vital role in the transcriptional networks with regards to human brain development. Currently, miRNAs' involvement in the pathogenesis of ADHD continues to be unclear. Therefore, this study aims to investigate the prospective role of miRNAs in ADHD and to determine whether miRNA levels in peripheral blood can serve as a biomarker and a diagnosis panel for ADHD. In the preliminary study, blood samples were collected from five patients with ADHD and five healthy control subjects. The use of Next Generation Sequencing (NGS) techniques has identified 23 miRNAs as potential biomarkers for ADHD. During this three-year proposal, we intend to recruit 100 drug-naïve patients with ADHD and 100 age- and gender-matched control subjects (Training Set). Blood will be obtained through direct puncture of the vein from each participant to analyze the miRNAs by using quantitative reverse transcription polymerase chain reaction (qRT-PCR). The behavior and neuropsychology of each participant will be assessed. This research will construct a miRNAs diagnosis panel using the Support Vector Machine (SVM) classification model to discriminate ADHD from non-ADHD. The validity of the miRNA diagnosis panel will then be re-examined using an independent validation sample composed of 50 patients with ADHD and 50 control subjects (Testing Set). All of the 150 patients with ADHD will receive treatment in a traditional clinical practice and then will be followed up with for 12 months. At the twelfth month, the same procedures as those performed at the baseline will be replicated to examine the influence of ADHD medications on miRNAs, as well as determine whether miRNAs can serve as a biomarker to portray the condition of ADHD under treatment. MiRNA target gene prediction and functional annotation analysis will also be performed. This study will develop a potential diagnostic panel for ADHD through the use of combinations of multiple miRNA expressions. We will provide proof of the relationships of miRNAs profiles and ADHD manifestations in clinical samples and further explain the molecular pathogenesis of ADHD. Such information may become an important reference for future research and clinical treatments for patients with ADHD.