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National Institutes of Health
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The Treatment of ADHD

Every family wants to determine what treatment will be most effective for their child. This question needs to be answered by each family in consultation with their health care professional. To help families make this important decision, the National Institute of Mental Health (NIMH) has funded many studies of treatments for ADHD and has conducted the most intensive study ever undertaken for evaluating the treatment of this disorder. This study is known as the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA).12 The NIMH is now conducting a clinical trial for younger children ages 3 to 5.5 years (Treatment of ADHD in Preschool-Age Children).

The Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder

The MTA study included 579 (95-98 at each of 6 treatment sites) elementary school boys and girls with ADHD, who were randomly assigned to one of four treatment programs: (1) medication management alone; (2) behavioral treatment alone; (3) a combination of both; or (4) routine community care. In each of the study sites, three groups were treated for the first 14 months in a specified protocol and the fourth group was referred for community treatment of the parents’ choosing. All of the children were reassessed regularly throughout the study period. An essential part of the program was the cooperation of the schools, including principals and teachers. Both teachers and parents rated the children on hyperactivity, impulsivity, and inattention, and symptoms of anxiety and depression, as well as social skills.

The children in two groups (medication management alone and the combination treatment) were seen monthly for one-half hour at each medication visit. During the treatment visits, the prescribing physician spoke with the parent, met with the child, and sought to determine any concerns that the family might have regarding the medication or the child’s ADHD-related difficulties. The physicians, in addition, sought input from the teachers on a monthly basis. The physicians in the medication-only group did not provide behavioral therapy but did advise the parents when necessary concerning any problems the child might have.

In the behavior treatment-only group, families met up to 35 times with a behavior therapist, mostly in group sessions. These therapists also made repeated visits to schools to consult with children’s teachers and to supervise a special aide assigned to each child in the group. In addition, children attended a special 8-week summer treatment program where they worked on academic, social, and sports skills, and where intensive behavioral therapy was delivered to assist children in improving their behavior.

Children in the combined therapy group received both treatments, that is, all the same assistance that the medication-only received, as well as all of the behavior therapy treatments.

In routine community care, the children saw the community-treatment doctor of their parents’ choice one to two times per year for short periods of time. Also, the community-treatment doctor did not have any interaction with the teachers.

The results of the study indicated that long-term combination treatments and the medication-management alone were superior to intensive behavioral treatment and routine community treatment. And in some areas—anxiety, academic performance, oppositionality, parent-child relations, and social skills—the combined treatment was usually superior. Another advantage of combined treatment was that children could be successfully treated with lower doses of medicine, compared with the medication-only group.

Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)

Because many children in the preschool years are diagnosed with ADHD and are given medication, it is important to know the safety and efficacy of such treatment. The NIMH is sponsoring an ongoing multi-site study, “Preschool ADHD Treatment Study” (PATS). It is the first major effort to examine the safety and efficacy of a stimulant, methylphenidate, for ADHD in this age group. The PATS study uses a randomized, placebo-controlled, double-blind design. Children ages 3 to 5 who have severe and persistent symptoms of ADHD that impair their functioning are eligible for this study. To avoid using medications at such an early age, all children who enter the study are first treated with behavioral therapy. Only children who do not show sufficient improvement with behavior therapy are considered for the medication part of the study. The study is being conducted at New York State Psychiatric Institute, Duke University, Johns Hopkins University, New York University, the University of California at Los Angeles, and the University of California at Irvine. Enrollment in the study will total 165 children.

Which Treatment Should My Child Have?

For children with ADHD, no single treatment is the answer for every child. A child may sometimes have undesirable side effects to a medication that would make that particular treatment unacceptable. And if a child with ADHD also has anxiety or depression, a treatment combining medication and behavioral therapy might be best. Each child’s needs and personal history must be carefully considered.

Medications

For decades, medications have been used to treat the symptoms of ADHD.

The medications that seem to be the most effective are a class of drugs known as stimulants. Following is a list of the stimulants, their trade (or brand) names, and their generic names. “Approved age” means that the drug has been tested and found safe and effective in children of that age.

Trade Name Generic Name Approved Age
Adderall amphetamine 3 and older
Concerta methylphenidate
(long acting)
6 and older
Cylert* pemoline 6 and older
Dexedrine dextroamphetamine 3 and older
Dextrostat dextroamphetamine 3 and older
Focalin dexmethylphenidate 6 and older
Metadate ER methylphenidate
(extended release)
6 and older
Metadate CD methylphenidate
(extended release)
6 and older
Ritalin methylphenidate 6 and older
Ritalin SR methylphenidate
(extended release)
6 and older
Ritalin LA methylphenidate
(long acting)
6 and older
*Because of its potential for serious side effects affecting the liver, Cylert should not ordinarily be considered as first-line drug therapy for ADHD.

The U.S. Food and Drug Administration (FDA) recently approved a medication for ADHD that is not a stimulant. The medication, Strattera®, or atomoxetine, works on the neurotransmitter norepinephrine, whereas the stimulants primarily work on dopamine. Both of theses neurotransmitters are believed to play a role in ADHD. More studies will need to be done to contrast Strattera with the medications already available, but the evidence to date indicates that over 70 percent of children with ADHD given Strattera manifest significant improvement in their symptoms.

Some people get better results from one medication, some from another. It is important to work with the prescribing physician to find the right medication and the right dosage. For many people, the stimulants dramatically reduce their hyperactivity and impulsivity and improve their ability to focus, work, and learn. The medications may also improve physical coordination, such as that needed in handwriting and in sports.

The stimulant drugs, when used with medical supervision, are usually considered quite safe. Stimulants do not make the child feel “high,” although some children say they feel different or funny. Such changes are usually very minor. Although some parents worry that their child may become addicted to the medication, to date there is no convincing evidence that stimulant medications, when used for treatment of ADHD, cause drug abuse or dependence. A review of all long-term studies on stimulant medication and substance abuse, conducted by researchers at Massachusetts General Hospital and Harvard Medical School, found that teenagers with ADHD who remained on their medication during the teen years had a lower likelihood of substance use or abuse than did ADHD adolescents who were not taking medications.13

The stimulant drugs come in long- and short-term forms. The newer sustained-release stimulants can be taken before school and are long-lasting so that the child does not need to go to the school nurse every day for a pill. The doctor can discuss with the parents the child’s needs and decide which preparation to use and whether the child needs to take the medicine during school hours only or in the evening and on weekends too.

If the child does not show symptom improvement after taking a medication for a week, the doctor may try adjusting the dosage. If there is still no improvement, the child may be switched to another medication. About one out of ten children is not helped by a stimulant medication. Other types of medication may be used if stimulants don’t work or if the ADHD occurs with another disorder. Antidepressants and other medications can help control accompanying depression or anxiety.

Sometimes the doctor may prescribe for a young child a medication that has been approved by the FDA for use in adults or older children. This use of the medication is called “off label.” Many of the newer medications that are proving helpful for child mental disorders are prescribed off label because only a few of them have been systematically studied for safety and efficacy in children. Medications that have not undergone such testing are dispensed with the statement that “safety and efficacy have not been established in pediatric patients.”

Side Effects of the Medications

Most side effects of the stimulant medications are minor and are usually related to the dosage of the medication being taken. Higher doses produce more side effects. The most common side effects are decreased appetite, insomnia, increased anxiety, and/or irritability. Some children report mild stomach aches or headaches.

Appetite seems to fluctuate, usually being low during the middle of the day and more normal by suppertime. Adequate amounts of food that is nutritional should be available for the child, especially at peak appetite times.

If the child has difficulty falling asleep, several options may be tried—a lower dosage of the stimulant, giving the stimulant earlier in the day, discontinuing the afternoon or evening dosage, or giving an adjunct medication such as a low-dosage antidepressant or clonidine. A few children develop tics during treatment. These can often be lessened by changing the medication dosage. A very few children cannot tolerate any stimulant, no matter how low the dosage. In such cases, the child is often given an antidepressant instead of the stimulant.

When a child’s schoolwork and behavior improve soon after starting medication, the child, parents, and teachers tend to applaud the drug for causing the sudden changes. Unfortunately, when people see such immediate improvement, they often think medication is all that’s needed. But medications don’t cure ADHD; they only control the symptoms on the day they are taken. Although the medications help the child pay better attention and complete school work, they can’t increase knowledge or improve academic skills. The medications help the child to use those skills he or she already possesses.

Behavioral therapy, emotional counseling, and practical support will help ADHD children cope with everyday problems and feel better about themselves.

Facts to Remember About Medication for ADHD

Medication for the Child with Both ADHD and Bipolar Disorder

Since a child with bipolar disorder will probably be prescribed a mood stabilizer such as lithium or Depakote®, the doctor will carefully consider whether the child should take one of the medications usually prescribed for ADHD. If a stimulant medication is prescribed, it may be given in a lower dosage than usual.