Antidepressant Medications for Children
Apr 28 2004
National Institute of Mental Health
Information for Parents and Caregivers from NIMH
Depression is a serious disease that causes significant problems at home, in school, and with peers. It increases a child's vulnerability to substance abuse, and puts them at risk for suicidal behaviors. Previous research has shown that depression in children and adolescents is a treatable condition. Psychological therapies, such as cognitive-behavioral therapy and interpersonal therapy, have been shown to be helpful for adolescents with depression. Medications, particularly the serotonin reuptake-blocking medications (SSRIs), have been shown to be of benefit in adults. Recently, however, concerns have been raised that antidepressant medications themselves may induce suicidal behavior and be ineffective in treating depression in youths. The National Institute of Mental Health (NIMH) offers the following information to help families and caregivers make treatment choices based on the best currently available information.
What Do We Know About Antidepressant Medications?
SSRIs (serotonin reuptake inhibitors) are considered an improvement over older antidepressants because they are better tolerated and are safer if taken in an overdose (which is an issue for patients at risk for suicide). They have been extensively tested in adult populations and have been proven to be safe and effective for adults. Note: Fluoxetine, sertraline, and fluvoxamine are approved by the FDA for the treatment of Obsessive-Compulsive Disorder because studies have shown they are safe and effective for adolescents with this disorder.
Use of SSRIs has risen dramatically in the past several years in children and adolescents age 10-19. Some research points out that this increase has coincided with a significant decrease in suicide rates in this age group, but it is not known if SSRIs are directly responsible for this improvement.
Fluoxetine has also been shown to be safe and helpful in treating depression in children 8 years and older in two different studies—one supported by NIMH and the other supported by Eli Lilly, the manufacturer of the drug. The studies found that it reduced depression for many children better than a placebo (a fake pill) and it did not increase suicide or suicidal thinking. However, fluoxetine failed to improve depression in at least one third of patients. Also, about one in 10 children experienced adverse side effects such as agitation and mania. The other SSRIs, such as sertraline, citalopram, paroxetine, and venlafaxine, have not been approved for treatment of depression in children or adolescents, though they have often been prescribed to children by physicians in "off-label use"—a use other than the approved use.
Some forms of psychotherapy, such as cognitive-behavioral therapy, have proven useful for adolescents with depression.
What Remains Unknown
Currently, there is no way of telling who may be sensitive to an SSRI's positive or adverse effects. Results thus far are based on populations—some individuals may show marked improvement, some may see no change, and some may be vulnerable to adverse effects. The response to medication of an individual patient cannot be predicted with certainty from the kind of studies that have been done so far.
It is extremely difficult to prove whether SSRIs increase the risk of suicide especially since suicide is already a significant risk in those who are depressed. In fact, no suicide has been reported among the more than 4,100 subjects enrolled in pediatric clinical trials of SSRIs. Controlled trials typically exclude patients considered at high risk for suicide, such as those with a history of suicide attempts.
The FDA is now re-analyzing existing data to try to determine if SSRIs raise the risk of suicide in children. It held a public advisory meeting in February to discuss the issue and in March requested that a warning of a possible association between use of SSRIs and suicidal behavior be inserted in the labeling of these medications.
What Should You Do for a Child With Depression?
Major depression in children and adolescents is a serious condition that should be adequately treated, which includes careful follow-up and monitoring.
Psychotherapy is the first choice for treatment of depression in children and adolescents, according to guidelines published by the American Academy of Child and Adolescent Psychiatry. Many times, psychotherapy accompanied by an early follow-up appointment may help to establish the persistence of depression before a decision is made to try antidepressant medications. Psychotherapy alternatives include "cognitive-behavioral therapy" and "interpersonal therapy."
Information for Parents and Caregivers from NIMH
Each child should be carefully and thoroughly evaluated by a physician to determine if medication is appropriate. Those who are prescribed an SSRI should receive ongoing medical monitoring, with particular care paid in the first few weeks of taking the drug.
Should nervousness, agitation, irritability, mood instability, or sleeplessness emerge or worsen during treatment with SSRIs, parents should obtain a prompt evaluation by a clinician with expertise in these medications.
Children already on any of the SSRIs should remain on the drug if it has been helpful but they should also be carefully monitored by a physician for evidence of side effects. Once started, treatment with these medications should not be abruptly stopped, because the body can react with further agitation and restlessness. Families should not discontinue treatment without consulting with their physician. All potentially effective treatments can be associated with side effects. A careful weighing of risks and benefits, with appropriate follow-up to help reduce risks, is the best that can be currently recommended.
What NIMH Is Doing
NIMH is conducting research to help clarify the potential value and risks of antidepressants, and to explore how medications compare with psychotherapy in adolescent depression. In particular, an NIMH-funded, multi-site controlled clinical trial, the Treatment for Adolescents with Depression Study (TADS), was launched in the late 1990s to directly compare the efficacy of fluoxetine, cognitive-behavioral therapy, and a combination of the two. Results are expected later in 2004.
Other studies are in progress to test the efficacy and safety of both medications and psychotherapy for youths with treatment-resistant depression and youths at increased risk for suicide attempts.
For more information on this topic, see: Antidepressant Medications in Children. Vitiello, B, Swedo, S. National Institute of Mental Health, Bethesda, MD. New England Journal of Medicine Apr 8;350(15):1489-91. See also http://content.nejm.org.
The SSRIs (serotonin reuptake inhibitors) include:
o fluoxetine (Prozac)
o sertraline (Zoloft)
o paroxetine (Paxil)
o citalopram (Celexa)
o escitalopram (Lexapro)
o fluvoxamine (Luvox)
o venlafaxine (Effexor)—another antidepressant closely related to the SSRIs