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NIH Publication No. 00-4702
Printed September 2000 |
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
1 in 5 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 twenty 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 |
* Due to 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 on Mental Disorders in Children, Contact:
Office of Communications and Public Liaison, NIMH
Information Resources and Inquiries Branch
6001 Executive Blvd., Room 8184, MSC 9663
Bethesda, MD 20892-9663
Phone: 301-443-4513
TTY: 301-443-8431
FAX: 301-443-4279
Mental Health FAX 4U: 301-443-5158
E-mail:
nimhinfo@nih.gov
NIMH home page address:
http://www.nimh.nih.gov
NIH-00-4702
September 2000 |