FDA CLEARS THE USE OF TMS IN ADOLESCENTS
In April the FDA cleared the use of Transcranial Magnetic Stimulation, or TMS, in patients aged 15-22 for the treatment of major depression. This is a long-awaited announcement, as TMS first approved for adults in 2008.
Adolescent depression is a serious and widespread problem. According to the CDC, 4.9% of children between the ages of six and seventeen have at some point been diagnosed with depression. Half of adolescents with depression fail to respond to current therapies and up to 70% of those who respond will relapse within 5 years.
The list of FDA approved treatments for adolescents is surprisingly short. Prozac (fluoxetine) was approved in 1987 for ages eight and older. Lexapro (escitalopram) was approved in 2009 for ages 12 and older. The more invasive treatment, electroconvulsive therapy (ECT) was approved by the FDA for adolescents in 2018.
Although most, or all of the existing antidepressants have been used off label by clinicians for decades, adding another officially cleared treatment modality is a big step forward.
Our analysis though, indicates that more research is called for, since the current findings are somewhat equivocal. The FDA clearance was granted to one of the TMS manufacturers, NeuroStar, which presented evidence in uncontrolled studies of 1,169 subjects, reporting clinically significant improvement in 78% of depressed adolescents.
There have been multiple other uncontrolled studies also demonstrating similarly high levels of effectiveness.
However, in medicine we must always be cognizant of the placebo effect, which is particularly strong in psychiatry and perhaps even stronger and something like TMS which has a certain dramatic element to it.
In the only sham (placebo) controlled study, Croarkin, et al. (Neuropsychopharmacol. 46, 462–469 (2021)) failed to show any separation from placebo.
Fortunately, in all the studies, the incidence of adverse effects in adolescents was extremely low, and was consistent with the low rate her side effects seen in adult patients. Common side effects include headaches and jaw pain. The only serious side effect, seizures, occurs in approximately 1/1000 patients, a rate comparable to that of antidepressants.
Given all of this data, our opinion is that TMS is a viable treatment option for some adolescents, but the bar should be somewhat higher than it is for adults, at least until more data is available. Adolescents should be evaluated on a case-by-case basis, and the risks and benefits should be weighed against other treatment options. Since this is a new indication, we do not yet know how or which insurers will be covering it yet.
We would be happy to discuss this with any potential patients, parents, or clinicians. You can reach our TMS coordinator, Ashley Oliver at 781-963-7775.
