Antidepressant Medications for Children and Adolescents: Information for Parents and Caregivers

Written by NIMH

Depression is a serious disorder that can cause significant problems in mood, thinking, and behavior at home, in school, and with peers. It is estimated that major depressive disorder (MDD) affects about 5 percent of adolescents.

Research has shown that, as in adults, depression in children and adolescents is treatable. Certain antidepressant medications, called selective serotonin reuptake inhibitors (SSRIs), can be beneficial to children and adolescents with MDD. Certain types of psychological therapies also have been shown to be effective. However, our knowledge of antidepressant treatments in youth, though growing substantially, is limited compared to what we know about treating depression in adults.

Recently, there has been some concern that the use of antidepressant medications themselves may induce suicidal behavior in youths. Following a thorough and comprehensive review of all the available published and unpublished controlled clinical trials of antidepressants in children and adolescents, the U.S. Food and Drug Administration (FDA) issued a public warning in October 2004 about an increased risk of suicidal thoughts or behavior (suicidality) in children and adolescents treated with SSRI antidepressant medications. In 2006, an advisory committee to the FDA recommended that the agency extend the warning to include young adults up to age 25.

More recently, results of a comprehensive review of pediatric trials conducted between 1988 and 2006 suggested that the benefits of antidepressant medications likely outweigh their risks to children and adolescents with major depression and anxiety disorders. The study, partially funded by NIMH, was published in the April 18, 2007, issue of the Journal of the American Medical Association.¹

What Did the FDA Review Find?

In the FDA review, no completed suicides occurred among nearly 2,200 children treated with SSRI medications. However, about 4 percent of those taking SSRI medications experienced suicidal thinking or behavior, including actual suicide attempts—twice the rate of those taking placebo, or sugar pills.

In response, the FDA adopted a "black box" label warning indicating that antidepressants may increase the risk of suicidal thinking and behavior in some children and adolescents with MDD. A black-box warning is the most serious type of warning in prescription drug labeling.

The warning also notes that children and adolescents taking SSRI medications should be closely monitored for any worsening in depression, emergence of suicidal thinking or behavior, or unusual changes in behavior, such as sleeplessness, agitation, or withdrawal from normal social situations. Close monitoring is especially important during the first four weeks of treatment. SSRI medications usually have few side effects in children and adolescents, but for unknown reasons, they may trigger agitation and abnormal behavior in certain individuals.

What Do We Know About Antidepressant Medications?

The SSRIs include:

• fluoxetine (Prozac)
• sertraline (Zoloft)
• paroxetine (Paxil)
• citalopram (Celexa)
• escitalopram (Lexapro)
• fluvoxamine (Luvox)

Another antidepressant medication, venlafaxine (Effexor), is not an SSRI but is closely related.

SSRI medications are considered an improvement over older antidepressant medications because they have fewer side effects and are less likely to be harmful if taken in an overdose, which is an issue for patients with depression already at risk for suicide. They have been shown to be safe and effective for adults.

However, use of SSRI medications among children and adolescents ages 10 to 19 has risen dramatically in the past several years. Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older. The other SSRI medications and the SSRI-related antidepressant venlafaxine have not been approved for treatment of depression in children or adolescents, but doctors still sometimes prescribe them to children on an "off-label" basis. In June 2003, however, the FDA recommended that paroxetine not be used in children and adolescents for treating MDD.

Fluoxetine can be helpful in treating childhood depression, and can lead to significant improvement of depression overall. However, it may increase the risk for suicidal behaviors in a small subset of adolescents. As with all medical decisions, doctors and families should weigh the risks and benefits of treatment for each individual patient.