Identifying ADHD is the First Step Toward Effective Treatment

Define ADHD and you have moved an important step closer to easing symptoms and improving your child's life. ADHD is a growing concern among parents today as more and more children are diagnosed every year with some form of the disorder. Fortunately for those children and their parents, a range of effective treatments are now available which bring with them new hope.

ADHD, or Attention Deficit Hyperactivity Disorder, is a social networking disorder that prevents those affected from interacting normally with their peers and society in general. An accurate ADHD definition will include common symptoms such as lack of concentration, hyperactivity, distractibility and impulsiveness, which can all make simply participating in school and work environments a struggle.

In most cases, ADHD is diagnosed in children. Some of the characteristics which define ADHD include becoming easily distracted, daydreaming excessively and not being able to concentrate and feelings of restlessness. An ADHD child will literally not be able to sit still long enough to be taught with standard methods, making them an almost daily disruption in most classrooms.

Because ADHD can last into adulthood, it can result in isolating those who suffer from it and preventing them from leading a normal life. Using a common ADHD definition, it is vital for the disorder to be recognized as soon as possible so that treatment can begin. The sooner an ADHD sufferer receives treatment, the better their odds of leading a normal, fulfilling life.

Until recently, the primary course of treatment once a doctor can define ADHD and accurately diagnose it is the use of stimulant based medications. While these medications can help to ease the restlessness and lack of concentration associated with ADHD, they also cause serious side effects and they do nothing to address the chemical and neurological imbalances which cause ADHD.

Fortunately, there are other options available for parents who don't want to subject their children to standard medications. With a generally accepted ADHD definition has come a clearer understanding of the disorder which, in turn, opened up new ways of addressing it. Everything from dietary changes to behavior management has been tried with varying levels of success.

By far the most exciting development in terms of treatment is the use of homeopathic remedies. Specially formulated using a blend of natural ingredients such as Hyoscyamus, Arsen iod, and Tuberculinum, these remedies work to both ease the symptoms which define ADHD and address the neurological imbalances which cause the disorder.

A diagnosis of ADHD may seem like the end of the world, but it doesn't have to be that way. The more we understand about this frustrating disorder, the more we can do to help those that suffer from it to live healthy, productive lives. So don't let ADHD stop you and your child in your tracks...consider all your options and find a treatment which works for you.

John Paduchak is a health researcher and the webmaster of http://adhd-planner.com, designed to help parents and those with ADD/ADHD find natural remedies & information to improve their lives. John has ADHD and is also a parent of 2 children with ADD/ADHD. One of his children's ADHD symptoms were so severe it forced him to do continual research on the subject and share it with everyone who might benefit from the effort in his sites. For information regarding the natural treatment and homeopathic remedies for ADHD and ADD visit http://natural-adhd-remedies.com

Shionogi Announces FDA Approval Of KAPVAY™ - The First And Only Therapy Approved For Use With Stimulant Medication For The Treatment Of ADHD

Main Category: ADHD
Also Included In: Regulatory Affairs / Drug Approvals;??Pharma Industry / Biotech Industry
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Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., announced the U.S. Food and Drug Administration approval of the non-stimulant medication KAPVAY™ (clonidine hydrochloride) extended-release tablets, an extended-release oral formulation for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6-17 years. KAPVAY™ is the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD, and is the first and only FDA-approved ADHD treatment indicated for use as add-on therapy to stimulant medication. KAPVAY™ can also be used as monotherapy when treating ADHD.

An oral, non-stimulant, twice-daily therapy, KAPVAY™ is a centrally acting alpha2-adrenergic receptor agonist. While the mechanism of action of alpha2 agonists in ADHD is not known, it is believed to involve the pre-frontal cortex (PFC) of the brain. Studies suggest that the PFC regulates attention and plays a critical role in impulse control, working memory and executive function.

"The FDA approval of KAPVAY™ represents an exciting milestone in the field of ADHD," said Donald C. Manning, MD, PhD, Chief Medical Officer of Shionogi Inc. "The extended-release formulation of KAPVAY™ minimizes the peaks and troughs in blood levels, thereby decreasing overactivation of the alpha receptors in the brain and periphery. We look forward to providing this important, beneficial treatment for ADHD to patients, both as monotherapy and add-on therapy to stimulants."

"ADHD is a complex disorder that requires individualized treatment. While there are prescription treatment options available, many ADHD patients on stimulants do not achieve adequate control of symptoms," explained Rakesh Jain, MD, MPH, Director of Psychiatric Drug Research for R/D Clinical Research at Lake Jackson, Texas, and an investigator in the clinical trials. "KAPVAY™, when added to a stimulant, addresses an unmet need, and improves ADHD symptoms beyond what is achieved by stimulants alone. This is a significant step forward for the treatment of ADHD to have an approved product for add-on therapy in our treatment armamentarium."

ADHD is a neurobehavioral disorder that occurs in childhood and may continue into adolescence and adulthood, which affects more than 4.5 million children ages 3-17 in the U.S. alone. Approximately 3-7 percent of U.S. school-aged children are believed to suffer from this disorder. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity/over-activity.

This approval is based on two Phase III studies, which demonstrated efficacy at 5-weeks that children and adolescents (6-17 years) with ADHD treated with KAPVAY™ experienced statistically significant improvements in core symptoms of ADHD inattention, hyperactivity and impulsivity. The most common and drug related adverse reactions (incident at least 5% and twice the rate of placebo) included somnolence, fatigue, upper respiratory tract infection (cough, rhinitis, sneezing), irritability throat pain (sore throat), insomnia, nightmares, emotional disorder, constipation, nasal congestion, increased body temperature, drug mouth and ear pain. Maintenance efficacy has not been systemically evaluated and patients who are continued on longer-term treatment require periodic reassessment.

About KAPVAY™

Administered orally, clonidine hydrochloride exerts its pharmacological effects as a centrally acting alpha2-adrenoceptor agonist. The formulation in KAPVAY™ is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences.

Important Safety Information

KAPVAY™ should not be used in patients with known hypersensitivity to clonidine.

KAPVAY™ has not been studied in children with ADHD less than 6-years old.

Use KAPVAY™ with caution in patients at risk for hypotension, bradycardia and heart block. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Advise patients to avoid becoming dehydrated or overheated.

Somnolence and sedation have been observed with KAPVAY™. Consider the potential for additive sedative effects with CNS depressant drugs. Caution patients against operating heavy equipment or driving until they know how they respond to KAPVAY™.

Patients should be instructed not to discontinue KAPVAY™ therapy without consulting their physician due to the potential risk of withdrawal effects. KAPVAY™ should be discontinued slowly in decrements of no more than 0.1 mg every 3 to 7 days.

In patients who have developed localized contact sensitization or other allergic reaction to clonidine in a transdermal system, substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash, urticaria or angioedema.

Use in patients with vascular disease, cardiac conduction disease, or chronic renal failure: Monitor carefully and uptitrate slowly.

Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.

Caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.

Do not use KAPVAY™ concomitantly with other products containing clonidine.

About Alpha2 Agonists

The prefrontal cortex (PFC) which regulates attention appears to be an important area of the brain affected in patients with ADHD. Specifically, studies suggest that the PFC plays a critical role in impulse control, working memory and executive function. Postsynaptic alpha2-adrenoceptors are one of several biological receptors important for PFC function.

About ADHD

ADHD is a neurobehavioral disorder that most often occurs in childhood and may continue into adolescence and adulthood. There are three subtypes of ADHD: predominantly hyperactive-impulsive, predominately inattentive, and combined hyperactive-compulsive and inattentive, with the latter being the most common. ADHD symptoms fall under three main categories: inattention, hyperactivity and impulsivity, which can include behaviors such as trouble focusing, frequent daydreaming, excessive talking, fidgeting/squirming, chronic impatience and difficulty waiting their turn, depending on the category.

The cause of ADHD is not yet known. However, research has shown potential links to genetic and environmental factors. While there is no cure for ADHD, the disorder can be managed with a variety of treatments including parental education and training, behavioral therapy and prescription medication.

ADHD is one of the most common childhood psychiatric disorders. In the United States alone, more than 4.5 million children ages 3-17 have been diagnosed, as of 2006. Approximately 3-7 percent of U.S. school-aged children are believed to suffer from this disorder. Boys are also more than twice as likely to be diagnosed (11 percent) as girls (4 percent).

Forward Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Source: Shionogi Inc

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First direct evidence that ADHD is a genetic disorder: Children with ADHD more likely to have missing or duplicated segments of DNA

ScienceDaily (Sep. 30, 2010) ? New research provides the first direct evidence that attention-deficit/hyperactivity disorder (ADHD) is a genetic condition. Scientists at Cardiff University found that children with ADHD were more likely to have small segments of their DNA duplicated or missing than other children.

The study also found significant overlap between these segments, known as copy number variants (CNVs), and genetic variants implicated in autism and schizophrenia, proving strong evidence that ADHD is a neurodevelopmental disorder -- in other words, that the brains of children with the disorder differ from those of other children.

The research, published in the journal The Lancet, was largely funded by the Wellcome Trust, with additional support from Action Medical Research, the Medical Research Council and the European Union.

"We hope that these findings will help overcome the stigma associated with ADHD," says Professor Anita Thapar. "Too often, people dismiss ADHD as being down to bad parenting or poor diet. As a clinician, it was clear to me that this was unlikely to be the case. Now we can say with confidence that ADHD is a genetic disease and that the brains of children with this condition develop differently to those of other children."

ADHD is one of the most common mental health disorders in childhood, affecting around one in 50 children in the UK. Children with ADHD are excessively restless, impulsive and distractible, and experience difficulties at home and in school. Although no cure exists for the condition, symptoms can be reduced by a combination of medication and behavioural therapy.

The condition is highly heritable -- children with ADHD are statistically more likely to also have a parent with the condition and a child with an identical twin with ADHD has a three in four chance of also having the condition. Even so, until now there has been no direct evidence that the condition is genetic and there has been much controversy surrounding its causes, which some people have put down to poor parenting skills or a sugar-rich diet.

The team at Cardiff University analysed the genomes of 366 children, all of whom had been given a clinical diagnosis of ADHD, against over 1,000 control samples in search of variations in their genetic make-up that were more common in children with the condition.

"Children with ADHD have a significantly higher rate of missing or duplicated DNA segments compared to other children and we have seen a clear genetic link between these segments and other brain disorders," explains Dr Nigel Williams. "These findings give us tantalising clues to the changes that can lead to ADHD."

The researchers found that rare CNVs were almost twice as common in children with ADHD compared to the control sample -- and even higher for children with learning difficulties. CNVs are particularly common in disorders of the brain.

There was also significant overlap between CNVs identified in children with ADHD and regions of the genome which are known to influence susceptibility to autism and schizophrenia. Whilst these disorders are currently thought to be entirely separate, there is some overlap between ADHD and autism in terms of symptoms and learning difficulties. This new research suggests there may be a shared biological basis to the two conditions.

The most significant overlap was found at a particular region on chromosome 16 which has been previously implicated in schizophrenia and other major psychiatric disorders and spans a number of genes including one known to play a role in the development of the brain .

"ADHD is not caused by a single genetic change, but is likely caused by a number of genetic changes, including CNVs, interacting with a child's environment," explains Dr Kate Langley. "Screening children for the CNVs that we have identified will not help diagnose their condition. We already have very rigorous clinical assessments to do just that."

Dr John Williams, Head of Neuroscience and Mental Health at the Wellcome Trust, which has supported Professor Thapar's work for ten years, says: "These findings are testament to the perseverance of Professor Thapar and colleagues to prove the often unfashionable theory that ADHD is a brain disorder with genetic links. Using leading-edge technology, they have begun to shed light on the causes of what is a complex and often distressing disorder for both the children and their families."

Editor's Note: This article is not intended to provide medical advice, diagnosis or treatment.

Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Wellcome Trust, via EurekAlert!, a service of AAAS.

Journal Reference:

Nigel M Williams, Irina Zaharieva, Andrew Martin, Kate Langley, Kiran Mantripragada, Ragnheidur Fossdal, Hreinn Stefansson, Kari Stefansson, Pall Magnusson, Olafur O Gudmundsson, Omar Gustafsson, Peter Holmans, Michael J Owen, Michael O'Donovan, Anita Thapar. Rare chromosomal deletions and duplications in attention-deficit hyperactivity disorder: a genome-wide analysis. Lancet, 2010; DOI: 10.1016/S0140-6736(10)61109-9

Note: If no author is given, the source is cited instead.

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