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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
NIH-00-4702
September 2000
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