ADHD clinical trials play an important role in defining the symptoms, the best treatment, appropriate therapy, the possible consequences of untreated ADHD, and more. The best clinical trials are those that are randomized and double blinded. This is done to rule out bias, and then depending on the findings of statistical significance can provide the background for providers to use when they make choices for treatment whether therapy, medications or both.
Much has been written and tried to improve behavior, moral defect, fidgets, mild brain damage, and emotionally distrubed children behaviors. It is not surprising that much has also been written about this ill defined approach and apparent experimenting with our children. In many cases these children and parents were faced with little hope. The link to ADHD is that in some cases these children also had some of the symptoms now linked to ADHD. Although we have always understood that the brain was complex, it has only been in the last 20 years scientists have made dramatic discoveries into the intricate nature of how the brain works. ADHD clinical trials since 1990 have been very specific and revealing.
Sir George Frederick Still, considered the father of British Paediatrics - described and published in the Lancet descriptions of 43 children with serious problems of sustained attention and self regulation. He also noted most of these children appeared to have a normal intellect. This was likely the first detailed Case Study of ADHD, although he used a term "Moral Defect" to describe the lack of control to see future consequences. However, for many people this put a negative spin in ADHD History.
Alfred F. Tredgold (a physician 1870-1952) describes high-grade-feeble minded children who must have a mild brain damage that causes them to have signs or symptoms of inattention or high activity impacting school work in his first addition of "Mental Deficiency" in 1908. Its 8th addition was published in the early 1950's and was used for physician training.
In 1937 Dr. Charles Bradley published his observations in 14 of 30 children with behavior problems who showed a "spectacular change in behavior and remarkably improved school performance" during 1 week of treatment with benzedrine (1, p. 582). This was the first and most important psychiatric treatment discovery for ADHD up to this time. His observations were published in the American Journal of Psychiatry The behavior of children receiving benzedrine. Am J Psychiatry 1937; 94:577-585. This can't be technically called one of the ADHD Clinical Trials, yet yielded important information about the response of ADHD like symptoms to stimulants.
Connors and Eisenberg investigated the effects of methylphenidate in a double blind study over a 10 day period in two groups of 81emotionally disturbed children. Overall improvement in the drug treated group was statistically significant. There were other questions such as appetite loss, and hints of anxiety increase. The drug effect was interpreted as activating an inhibitory control mechanism in the brain to control the symptoms. Because a wide variation of response it was recommended that further research into these differences and factors involved is required and to use caution in this drugs use. (Note: these children were not diagnosed with ADHD alone, in fact DSM IV diagnosis criteria were not out yet).
The perfect storm: ADHD clinical trials did not exist yet - ADHD had not been fully defined yet - not until 1987 did the term ADHD actually show up in the DSM-IV. However, much independent work was being done trying to help children and youth with behavior difficulties. Some of them had hyperactivity, impulsiveness, and inattention, but many also had other symptoms. There was little interest from drug companies to get involved at this time because they did not want to sponsor studies in children who unspecified diagnosis so their focus remained with adults.
The NIMH (National Institute of Mental Health) concluded that quality studies were needed using established, consistent, and stringent criteria, that looked into the short term and long term efficacy of the various classes of drugs that were randomly being used as well as safety. Three grants were given to: Univ. of California - Davis, Hillside Hospital of New York, and the District of Columbia's Dept. of Mental Health to specifically study drugs effects in Hyperkinetic Children and the Pharmacotherapy of Hyperactive Children.
At the beginning of 1970, it was estimated that only 0.0002 percent of US children were taking any stimulant. Nevertheless, as seen on the ADHD History page, the Washington Post published an article in which it implied that 5-10 percent of children in Omaha were given methylphenidate and that their parents were coerced to have their children take it, with inadequate medical supervision and there was pill swapping in the schools.
Even though parents in Omaha were not coerced to give their children methylphenidate, and only 5-10 percent of the children in special education received the medication and not the entire population of students, this stirred considerable media attention and led to National Conferences, Congressional Actions, the DEA to get involved. Also seen were a number of books touting ADHD as a mystery diagnosis, Causes of ADHD that are totally allergic related and many others. There were some who accused the Government of trying to drug our children. This was not the case.
There have been many ADHD clinical trials published in the last 30 years. All medications today that are approved for the treatment of ADHD in children or adults have clinical trials on file with the FDA that prove their efficacy in these respective areas. Each of these companies offer extensive websites for their respective medications. It would be hard to give a summary of those studies on this page. Below is a link that updates current ADHD Clinical Trials and ADHD News as it gets published.
One of the largest and most important of the ADHD Clinical Trials was funded by the NIMH (National Institute of Mental Health) and the results werepublished in 1999, from a 14-month study, known as theMultimodal Treatment Study of ADHD (MTA Study); It involved more than 570 children with ADHD at six sites in the United States and Canada. Results showed that medication alone was more effective than psychosocial treatments alone, but that the combination of medication and psychosocial or behavior therapy was more beneficial than medication alone.
To find newly published ADHD Clinical Studies, research and news that relate to ADHD from Medical News Today, click here.
While the symptoms of hyperactivity and inattention have been described for centuries, it has only been very recently that ADHD has been defined as a separate and distinct diagnosis. Many patients can have these symptoms but they can be caused by other illnesses or conditions. The Brain is a very complex organ and the work to understand the different components, functions and the different illnesses that can result from the brains malfunction, led to confusion not just for the treatment of ADHD symptoms, the same issues existed for all the other brain diagnostic illnesses. It wasn't until the 1980's that scientists began to more fully understand the brain and how it works. Today, ADHD has been specifically defined and its treatment has been studied using very stringent criteria.
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