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New Medications Buspirone and Adderall
Although Ritalin is still the most widely prescribed medication for treating ADHD/ADD, and the safety and efficacy of this medication are well established, not all children do well on this medication. Some children do not show the positive response that most do, and others experience side effects that make the ongoing use of Ritalin problematic.
For these reasons, new medications that can be effective in treating the symptoms of ADHD continue to be important to develop. In this issue of ADHD RESEARCH UPDATE I'd like to report on two recent studies that were conducted to test new medications for treating ADHD.
The April 1998 issue of the Journal of the American Academy of Child and Adolescent Psychiatry presents a study that offers some preliminary support for the use of Buspirone in treating ADHD. Buspirone has been used since 1984 to treat children and teens with anxiety disorders and it has been reported to be effective for such conditions. In addition, side effects (these include nausea, headaches, daytime tiredness and weight gain) to Buspirone are reported to be uncommon and to be only mild or moderate when they do occur.
In this study, 12 children with ADHD between the ages of 6-12 were treated with Buspirone over a 6 week period and systematic assessments of children's behavior were completed by parents on a weekly basis. All children received the medication twice per day. At the end of the 6 weeks, the medication was discontinued and a final set of parent ratings was obtained 2 weeks later.
The effectiveness of Buspirone in reducing core ADHD symptoms AND in reducing oppositional/aggressive behavior was quite impressive. By the end of the 6 week trial, all subjects were reported to have shown a reduction in symptoms of at least 50% on the behavior rating scales completed by their parents. In addition, significant and substantial in children's overall functioning was also reported. When the medication was discontinued temporarily for 2 weeks at the end of the trial, all 12 children showed a reemergence of symptoms within 2 weeks. During the trial, only 2 children reported any side effects at all (i.e. mild dizziness) and this abated after the first week.
These results are obviously quite promising, although as the authors readily acknowledge this is an initial demonstration only. Subsequent studies will need to include larger samples, an adequate control group, and should also include ratings from teachers as well as parents.
Hopefully, these necessary follow up studies will be conducted and reported shortly, because Buspirone may have several important advantages compared to stimulant medications in that it has a very favorable side effects profile and for parents who are concerned about this, it also has no reported abuse potential.
The May 1998 issue of the Journal of the American Academy of Child and Adolescent Psychiatry reports the results of a carefully designed study to test the effectiveness of Adderall, which is a relatively new type of stimulant medication that is being used more frequently to treat ADHD.
Adderall was initially approved by the FDA for the treatment of obesity and "minimal brain dysfunction" in the 1960's. In 1994, Richwood Pharmaceuticals began marketing Adderall specifically to treat ADHD. Among the reported advantages relative to Ritalin are that it lasts longer - meaning that fewer doses per day are possible - and that children are less likely to show the "rebound effect" (i.e. a temporary increase in irritability and ADHD symptoms as the medication wears off).
Thirty-three children with a confirmed diagnosis of ADHD between the ages of 7 and 14 served as subjects in this study. All children who participated were currently being treated with methylphenidate (i.e. the generic name for Ritalin) and had been shown to have a good response to their medication. During the study, children were tried on 4 different doses of Adderall (i.e. 5 mg, 10 mg, 15 mg, and 20 mg.) They were also placed on a placebo for 1 week and were evaluated for one week on their regular dose of methylphenidate. Children received the different doses in a random order - in other words, some children might receive the highest dose during their first week while others might start with the lowest dose. This differs, of course, from the typical procedure of starting at the lowest possible dose and gradually building up to a level that yields a strong response.
During the trial, students participated in an experimental classroom that was designed to be similar to a typical classroom environment. The schedule of daily activities was tightly adhered to, however, so that children could be systematically observed performing particular tasks at set times after taking the medication in the morning. This enabled the researchers to track whether and how children's performance changed over the course of the day in a systematic manner. With this information, the duration of benefits provided by the medication could be carefully assessed.
During the trial, ratings of children's behavior and attention were collected by independent observers in children's class- rooms. These observers did not know what dose children were receiving, or when they were on a placebo as opposed to real medication. This placebo condition is important because by comparing ratings for the real medication weeks with the placebo week one can then determine whether any improvements from medication are above and beyond what is produced by a placebo alone. In addition to ratings of attention and behavior, data was also collected on the percent of assigned math problems attempted and the percentage that were answered. Thus, the authors sought to evaluate the impact of Adderall not just on children's behavior, but also on the quality of their academic performance.
The authors first present data on side effects. As has been found in studies with other stimulant medications, reports of side effects were no more frequent or severe in most medication conditions than in the placebo condition. At higher doses, however, there were more reports of sleep difficulties and appetite reduction from children's parents. During the placebo week, children's behavior deteriorated significantly over the course of the day. Children also attempted fewer assigned problems and completed fewer problems correctly as the day wore on. In contrast to this decline during the day for behavior and school work, ratings of attention remained relatively constant over the day - i.e. they were equally problematic throughout.
During the medication weeks, the same decline in behavior and school work was not observed. Instead, children showed an initial improvement in both these areas that began to reverse as the medication wore off. As for academic work, children attempted more problems and answered a higher percentage correctly when on medication, although this also changed as the medicine wore off. Overall, greater benefits were obtained at higher doses, although the optimum dose for each individual child varied. Although the study was not designed to compare the effectiveness of Adderall and methylphenidate, overall children seemed to do equally well on both.
In comparing methylphenidate with Adderall, the authors reports that the peak effects (i.e. the time required to reach the greatest benefit of methylphenidate occurred quicker than for Adderall (i.e. 1.88 hours vs. 1.50, 2.60, 2.60, and 3.50 for the 5, 10, 15 and 20 mg doses respectively). The beneficial effects of methylphenidate were of shorter duration however (i.e. 3.98 hours vs. 3.52, 4.83, 5.44, and 6.40 hours for the different Adderall doses). It is important to note that these times represent group averages and can thus vary considerably between individual children.
What are the important clinical implications of these studies for parents trying to help their child? There are several. First and foremost, it is essential to realize that there are multiple medications that have been shown to have demonstrated efficacy for treating ADHD. For a child who does not respond well to the first medication tried (this is generally Ritalin) there are other options available. Unfortunately, there are many instances, I think, where failure to get good results with an initial medication is not followed by systematic efforts to find a medication that will be effective. As a result, many children who could really be deriving important benefits from medication are not getting treatment that could be quite helpful to them.
The same issue holds true for side effects. In my experience, if a child experiences side effects on the medication first tried parents are reluctant to try anything else. Just because a child has an adverse reaction to one type of medication, however, does not mean that similar problems will occur on a different medicine. In addition, in many cases what appear to be side effects to medication will actually be nothing more than a placebo effect. this is another reason why carefully conducted trials in which a child's response to medication is compared to placebo is so important.
Please do not interpret this to mean that I am advocating the use of medication for any child diagnosed with ADHD. As reported in the last issue of ADHD RESEARCH UPDATE there is still disagreement about this issue among experts, with some very well regarded psychologists advocating the use of behavioral interventions prior to any decision about the need for medication is made. If it does make sense to try medication for a child with ADHD, however, it is important to know what the different options are and what the best procedure is for determining the optimal dose and medication for each individual child.
Note: This article originally appeared in Attention Research Update, an online newsletter written by Dr. David Rabiner, a Duke University psychologist and former member of CHADD's Professional Advisory Board. You can learn more about Attention Research Update and sign up for a free subscription at www.helpforadd.com.