Provided by the National Institute of Mental Health
A Note to Parents
There has been public concern over reports that very young children are being
prescribed psychotropic medications. The studies to date are incomplete, and
much more needs to be learned about young children who are treated with
medications for all kinds of illnesses. In the field of mental health, new
studies are needed to tell us what the best treatments are for children with
emotional and behavioral disturbances.
Children are in a state of rapid change and growth during their developmental
years. Diagnosis and treatment of mental disorders must be viewed with these
changes in mind. While some problems are short-lived and don't need treatment,
others are persistent and very serious, and parents should seek professional
help for their children.
Not long ago, it was thought that many brain disorders such as anxiety
disorders, depression, and bipolar disorder began only after childhood. We now
know they can begin in early childhood. An estimated 1 in 10 children and
adolescents in the United States suffers from mental illness severe enough to
cause some level of impairment. Fewer than one in five of these ill children
receives treatment. Perhaps the most studied, diagnosed, and treated
childhood-onset mental disorder is attention deficit hyperactivity disorder
(ADHD), but even with this disorder there is a need for further research in very
young children.
This booklet contains answers to frequently asked questions regarding the
treatment of children with mental disorders.
Questions and Answers
Q: What should I do if I am concerned about mental, behavioral, or emotional
symptoms in my young child?
A: Talk to your child's doctor. Ask questions and find out everything you can
about the behavior or symptoms that worry you. Every child is different and even
normal development varies from child to child. Sensory processing, language, and
motor skills are developing during early childhood, as well as the ability to
relate to parents and to socialize with caregivers and other children. If your
child is in daycare or preschool, ask the caretaker or teacher if your child has
been showing any worrisome changes in behavior, and discuss this with your
child's doctor.
Q: How do I know if my child's problems are serious?
A: Many everyday stresses cause changes in behavior. The birth of a sibling may
cause a child to temporarily act much younger. It is important to recognize such
behavior changes, but also to differentiate them from signs of more serious
problems. Problems deserve attention when they are severe, persistent, and
impact on daily activities. Seek help for your child if you observe problems
such as changes in appetite or sleep, social withdrawal, or fearfulness;
behavior that seems to slip back to an earlier phase such as bed-wetting; signs
of distress such as sadness or tearfulness; self-destructive behavior such as
head banging; or a tendency to have frequent injuries. In addition, it is
essential to review the development of your child, any important medical problem
he/she might have had, family history of mental disorders, as well as physical
and psychological traumas or situations that may cause stress.
Q: Whom should I consult to help my child?
A: First, consult your child's doctor. Ask for a complete health examination of
your child. Describe the behaviors that worry you. Ask whether your child needs
further evaluation by a specialist in child behavioral problems. Such
specialists may include psychiatrists, psychologists, social workers, and
behavioral therapists. Educators may also be needed to help your child.
Q: How are mental disorders diagnosed in young children?
A: Similar to adults, disorders are diagnosed by observing signs and symptoms. A
skilled professional will consider these signs and symptoms in the context of
the child's developmental level, social and physical environment, and reports
from parents and other caretakers or teachers, and an assessment will be made
according to criteria established by experts. Very young children often cannot
express their thoughts and feelings, which makes diagnosis a challenging task.
The signs of a mental disorder in a young child may be quite different from
those of an older child or an adult.
Q: Won't my child get better with time?
A: Sometimes yes, but in other cases children need professional help. Problems
that are severe, persistent, and impact on daily activities should be brought to
the attention of the child's doctor. Great care should be taken to help a child
who is suffering, because mental, behavioral, or emotional disorders can affect
the way the child grows up.
Q: Which mental disorders are seen in children?
A: Mental disorders with possible onset in childhood include: anxiety disorders;
attention deficit and disruptive behavior disorders; autism and other pervasive
developmental disorders; eating disorders (e.g., anorexia nervosa); mood
disorders (e.g., major depression, bipolar disorder); schizophrenia; and tic
disorders. Under some circumstances, bed-wetting and soiling may be symptoms of
a mental disorder.
Q: Are there situations in which it is advisable to use psychotropic medications
in young children?
A: Psychotropic medications may be prescribed for young children with mental,
behavioral, or emotional symptoms when the potential benefits of treatment
outweigh the risks. Some problems are so severe and persistent that they would
have serious negative consequences for the child if untreated, and psychosocial
interventions may not always be effective by themselves. The safety and efficacy
of most psychotropic medications have not yet been studied in young children. As
a parent, you will want to ask many questions and evaluate with your doctor the
risks of starting and continuing your child on these medications. Learn
everything you can about the medications prescribed for your child, including
potential side effects. Learn which side effects are tolerable and which ones
are threatening. In addition, learn and keep in mind the goals of a particular
treatment (e.g., change in specific behaviors). Combining multiple psychotropic
medications should be avoided in very young children unless absolutely
necessary.
Q: Does medication affect young children differently from older children or
adults?
A: Yes. Young children's bodies handle medications differently than older
individuals and this has implications for dosage. The brains of young children
are in a state of very rapid development, and animal studies have shown that the
developing neurotransmitter systems can be very sensitive to medications. A
great deal of research is still needed to determine the effects and benefits of
medications in children of all ages. Yet it is important to remember that
serious untreated mental disorders themselves negatively impact brain
development.
Q: If my preschool child receives a diagnosis of a mental disorder, does this
mean that medications have to be used?
A: No. Psychotropic medications are not generally the first option for a
preschool child with a mental disorder. The first goal is to understand the
factors that may be contributing to the condition. The child's own physical and
emotional state is key, but many other factors such as parental stress or a
changing family environment may influence the child's symptoms. Certain
psychosocial treatments may be as effective as medication.
Q: How should medication be included in an overall treatment plan?
A: When medication is used, it should not be the only strategy. There are other
services that you may want to investigate for your child. Family support
services, educational classes, behavior management techniques, as well as family
therapy and other approaches should be considered. If medication is prescribed,
it should be monitored and evaluated regularly.
Q: What medications are used for which kinds of childhood mental disorders?
A: There are several major categories of psychotropic medications: stimulants,
antidepressants, antianxiety agents, antipsychotics, and mood stabilizers. For
medications approved by the FDA for use in children, dosages depend on body
weight and age. The Medications Chart in this booklet shows the most commonly
prescribed medications for children with mood or anxiety disorders (including
OCD).
Stimulant Medications: There are four stimulant medications that are approved
for use in the treatment of attention deficit hyperactivity disorder (ADHD), the
most common behavioral disorder of childhood. These medications have all been
extensively studied and are specifically labeled for pediatric use. Children
with ADHD exhibit such symptoms as short attention span, excessive activity, and
impulsivity that cause substantial impairment in functioning. Stimulant
medication should be prescribed only after a careful evaluation to establish the
diagnosis of ADHD and to rule out other disorders or conditions. Medication
treatment should be administered and monitored in the context of the overall
needs of the child and family, and consideration should be given to combining it
with behavioral therapy. If the child is of school age, collaboration with
teachers is essential.
Antidepressant and Antianxiety Medications: These medications follow the
stimulant medications in prevalence among children and adolescents. They are
used for depression, a disorder recognized only in the last 20 years as a
problem for children, and for anxiety disorders, including obsessive-compulsive
disorder (OCD). The medications most widely prescribed for these disorders are
the selective serotonin reuptake inhibitors (the SSRIs).
In the human brain, there are many "neurotransmitters" that affect the way we
think, feel, and act. Three of these neurotransmitters that antidepressants
influence are serotonin, dopamine, and norepinephrine. SSRIs affect mainly
serotonin and have been found to be effective in treating depression and anxiety
without as many side effects as some older antidepressants.
Antipsychotic Medications: These medications are used to treat children with
schizophrenia, bipolar disorder, autism, Tourette's syndrome, and severe conduct
disorders. Some of the older antipsychotic medications have specific indications
and dose guidelines for children. Some of the newer "atypical" antipsychotics,
which have fewer side effects, are also being used for children. Such use
requires close monitoring for side effects.
Mood Stabilizing Medications: These medications are used to treat bipolar
disorder (manic-depressive illness). However, because there is very limited data
on the safety and efficacy of most mood stabilizers in youth, treatment of
children and adolescents is based mainly on experience with adults. The most
typically used mood stabilizers are lithium and valproate (Depakote®), which are
often very effective for controlling mania and preventing recurrences of manic
and depressive episodes in adults. Research on the effectiveness of these and
other medications in children and adolescents with bipolar disorder is ongoing.
In addition, studies are investigating various forms of psychotherapy, including
cognitive-behavioral therapy, to complement medication treatment for this
illness in young people.
Effective treatment depends on appropriate diagnosis of bipolar disorder in
children and adolescents. There is some evidence that using antidepressant
medication to treat depression in a person who has bipolar disorder may induce
manic symptoms if it is taken without a mood stabilizer. In addition, using
stimulant medications to treat co-occurring ADHD or ADHD-like symptoms in a
child with bipolar disorder may worsen manic symptoms. While it can be hard to
determine which young patients will become manic, there is a greater likelihood
among children and adolescents who have a family history of bipolar disorder. If
manic symptoms develop or markedly worsen during antidepressant or stimulant
use, a physician should be consulted immediately, and diagnosis and treatment
for bipolar disorder should be considered.
Q: What difference does it make if a medication is specifically approved for use
in children or not?
A: Approval of a medication by the FDA means that adequate data have been
provided to the FDA by the drug manufacturer to show safety and efficacy for a
particular therapy in a particular population. Based on the data, a label
indication for the drug is established that includes proper dosage, potential
side effects, and approved age. Doctors prescribe medications as they feel
appropriate even if those uses are not included in the labeling. Although in
some cases there is extensive clinical experience in using medications for
children or adolescents, in many cases there is not. Everyone agrees that more
studies in children are needed if we are to know the appropriate dosages, how a
drug works in children, and what effects there are on learning and development.
Q: What does "off-label" use of a medication mean?
A: Many medications that are on the market have not been officially approved by
the FDA for use in children. Treatment of children with these medications is
called "off-label" use. For some medications, the off-label use is supported by
data from well-conducted studies in children. For instance, some antidepressant
medications have been shown to be effective in children and adolescents with
depression. For other medications, there are no controlled studies in children,
but only isolated clinical reports. In particular, the use of psychotropic
medications in preschoolers has not been adequately studied and must be
considered very carefully by balancing severity of symptoms, degree of
impairment, and potential benefits and risks of treatment.
Q: Why haven't many medications been tested in children?
A: In the past, medications were not studied in children because of ethical
concerns about involving children in clinical trials. However, this created a
new problem: lack of knowledge about the best treatments for children. In
clinical settings where children are suffering from mental or behavioral
disorders, medications are being prescribed at increasingly early ages. The FDA
has been urging that products be appropriately studied in children and has
offered incentives to drug manufacturers to carry out such testing. The NIH and
the FDA are examining the issue of medication research in children and are
developing new research approaches.
Q: Does the FDA approve medications for different age groups among children?
A: Yes. However, this is based on the data provided to the FDA by the drug
manufacturer and the policies in effect at the time of approval. For example,
Ritalin® is approved for children age 6 and older, whereas Dexedrine® is
approved for children as young as 3. When Ritalin® was tested for efficacy by
its manufacturer, only children age 6 and above were involved; therefore, age 6
was approved as the lower age limit for Ritalin®.
Q: Can events such as a death in the family, illness in a parent, onset of
poverty, or divorce cause symptoms?
A: Yes. When a tragedy occurs or some extreme stress hits, every member of a
family is affected, even the youngest ones. This should also be considered when
evaluating mental, emotional, or behavioral symptoms in a child.
--------------------------------------------------------------------------------
Medications Chart
Stimulant Medications
Brand Name Generic Name Approved Age
Adderall amphetamines 3 and older
Concerta methylphenidate 6 and older
Cylert* pemoline 6 and older
Dexedrine dextroamphetamine 3 and older
Dextrostat dextroamphetamine 3 and older
Ritalin methylphenidate 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.
Antidepressant and Antianxiety Medications
Brand Name Generic Name Approved Age
Anafranil clomipramine 10 and older (for OCD)
BuSpar buspirone 18 and older
Effexor venlafaxine 18 and older
Luvox (SSRI) fluvoxamine 8 and older (for OCD)
Paxil (SSRI) paroxetine 18 and older
Prozac (SSRI) fluoxetine 18 and older
Serzone (SSRI) nefazodone 18 and older
Sinequan doxepin 12 and older
Tofranil imipramine 6 and older (for bed-wetting)
Wellbutrin bupropion 18 and older
Zoloft (SSRI) sertraline 6 and older (for OCD)
Antipsychotic Medications
Brand Name Generic Name Approved Age
Clozaril(atypical) clozapine 18 and older
Haldol haloperidol 3 and older
Risperdal (atypical) risperidone 18 and older
Seroquel (atypical) quetiapine 18 and older
(generic only) thioridazine 2 and older
Zyprexa (atypical) olanzapine 18 and older
Orap pimozide 12 and older (for Tourette’s syndrome).
Data for age 2 and older indicate similar safety profile.
Mood Stabilizing Medications
Brand Name Generic Name Approved Age
Cibalith-S lithium citrate 12 and older
Depakote divalproex sodium 2 and older (for seizures)
Eskalith lithium carbonate 12 and older
Lithobid lithium carbonate 12 and older
Tegretol carbamazepine any age (for seizures)
--------------------------------------------------------------------------------
References
Burns BJ, Costello EJ, Angold A, Tweed D, Stangl D, Farmer EM, Erkanli A. Data
Watch: children's mental health service use across service sectors. Health
Affairs, 1995; 14(3): 147-59.
Coyle JT. Psychotropic drug use in very young children [editorial]. Journal of
the American Medical Association, 2000; 283(8): 1059-60.
Physician's Desk Reference (PDR). Montvale, NJ: Medical Economics Company, 1999.
Shaffer D, Fisher P, Dulcan MK, Davies M, Piacentini J, Schwab-Stone ME, Lahey
BB, Bourdon K, Jensen PS, Bird HR, Canino G, Regier DA. The NIMH diagnostic
interview schedule for children version 2.3 (DISC 2.3): description,
acceptability, prevalence, rates, and performance in the MECA study. Journal of
the Academy of Child and Adolescent Psychiatry, 1996; 35(7): 865-77.
Zito JM, Safer DJ, dosReis S, Gardner JF, Botes M, Lynch F. Trends in the
prescribing of psychotropic medications to preschoolers. Journal of the American
Medical Association, 2000; 283(8): 1025-30.
--------------------------------------------------------------------------------
For More Information
Please vist the following link for more information about organizations that
focus on children and adolescent mental health.
NIH-04-4702
Reprinted April 2004
Back to Mental Health Articles