Pediatric Dysthymic Disorder Medication
- Author: Edwin S Rogers, PhD, ABPP; Chief Editor: Caroly Pataki, MD more...
Medication Summary
According to the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters, few studies are available to inform the use of antidepressant medication in children with dysthymic disorder. However, studies of adult patients with dysthymic disorder have shown that tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and monoamine oxidase inhibitors (MAOIs) are effective in treating dysthymic disorder at the same doses that are effective against major depressive disorder.
"[B]ased on the limited adult literature, efficacious treatment for [major depressive disorder] may also be useful for the management of [dysthymic disorder]," states the AACAP.[7] However, the US Food and Drug Administration (FDA) has approved only a handful of the multiple drugs in the first 2 of the above 3 classes for use in depression (or for other indications) in children and adolescents.
Because most medications administered to children have not been extensively studied in the pediatric population, the information below is given with the understanding that this use reflects current practice among child and adolescent psychiatrists. As a patient's age approaches adolescence, the physician can be more confident that the treatment is likely to be as effective as it is for the disorder in adulthood.
Current consensus is that SSRIs are greatly preferred over the other classes of antidepressants. The adverse effect profile is less prominent, promoting compliance. SSRIs are also much safer from a medical standpoint, without the risk of cardiac arrhythmia observed in TCAs. Such a risk is especially pertinent in overdose; suicide risk always must be considered in the treatment of a child or adolescent with a mood disorder.
Selective Serotonin Reuptake Inhibitors
Class Summary
SSRIs are antidepressant agents chemically unrelated to the tricyclic, tetracyclic, or other available antidepressants. They inhibit central nervous system (CNS) neuronal uptake of serotonin (5HT). They may also have a weak effect on norepinephrine and dopamine neuronal reuptake.
Increasing controversy surrounds the use of SSRIs in the pediatric population. In December 2003, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued an advisory that most SSRIs are not suitable for use by persons younger than 18 years for treatment of "depressive illness." After review, this agency decided that the risks to pediatric patients outweigh the benefits of treatment with SSRIs, with the exception of fluoxetine (Prozac), which appears to have a positive risk-benefit ratio in the treatment of depressive illness in patients younger than 18 years.
In October 2003, the FDA issued a public health advisory regarding reports of suicidality in pediatric patients treated with antidepressant medications for major depressive disorder (not dysthymic disorder). This advisory reported suicidality (ideation and attempts) in clinical trials of various antidepressant drugs in pediatric patients. Nonetheless, the FDA has asked that additional studies be performed because suicidality occurred in treated and untreated patients with major depression and thus could not be linked to drug treatment.[9]
In March 2004, the FDA issued a public health advisory regarding several antidepressant medications, partly in response to their use in the pediatric population. For more information, see the FDA advisory statement on worsening depression and risk of suicidality with antidepressant drugs.[10]
After the initiation of medical treatment, physicians are advised by the FDA to closely monitor patients for worsening depression or suicidality and for signs of mania or hypomania development. Furthermore, the FDA advisory specifically states that health care providers should instruct patients, families, and caregivers to be alert for the emergence of suicidality, worsening depression, agitation, irritability, and other symptoms (eg, anxiety, panic attacks, insomnia, hostility, impulsivity, akathisia, hypomania, mania) and to immediately report such symptoms to the health care provider.
In October 2004, the FDA issued a public health advisory intended to warn the public about the risks of increasing suicidality among adolescents and children treated with antidepressants. The FDA’s efforts included the requirement of a "black box" warning on medication labeling directed to prescribers and the development of patient information materials to inform consumers of the potential risks of suicidal behavior in depressed pediatric patients. For more information, see information specific to certain antidepressants from the FDA.
According to a report by Cheung et al, prescribing of antidepressants by pediatricians (psychiatrists were not part of this study) decreased after the FDA issued the black box requirement.[11]
However, a study of more than 65,000 children and adults treated for depression between 1992 and 2002 by the Group Health Cooperative in Seattle found a decline, rather than a rise, in suicide risk with the use of antidepressants.[12] This is the largest study to date to address this issue.
Currently, evidence does not exist to associate an increased suicide risk with the treatment of obsessive-compulsive disorder (OCD) or other anxiety disorders with SSRIs.
Note that fluoxetine is the only medication approved by the FDA to treat depression in children aged 7 years and older. Other medications are used off-label.
The FDA's recommendations are sound with regard to the treatment and monitoring of all patients with mood disorders, whether or not medication is used. Because treatment response and the course of the illness vary, ongoing monitoring for increasing severity of the illness and the development of more intense symptoms is wise.
Physicians are advised to be aware of the above information and to use appropriate caution when considering treatment with antidepressant medications in the pediatric population.[13]
Fluoxetine (Prozac)
Fluoxetine is FDA approved for depression in children 7-17 years. The drug, which has a half-life is of 7-9 days, selectively inhibits presynaptic serotonin reuptake.
Sertraline (Zoloft)
Sertraline is FDA approved for the treatment of OCD in children aged 6 years and older. It is also used off label for depression in children. The drug selectively inhibits presynaptic serotonin reuptake.
Fluvoxamine (Luvox)
Fluvoxamine is FDA approved for OCD in children older than 8 years. It is also used off label in children for depression. The drug selectively inhibits presynaptic serotonin reuptake.
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