Synopsis: The FDA got it right when they approved TMS therapy for adolescent depression (kids aged 15 and older). TMS is one of the most effective treatments for resistant depression. The decision to approve this treatment for kids is an absolute game-changer and will save many young lives. This article describes the dramatic impact of the FDA’s approval and covers research that shows TMS for kids to be safe, well-tolerated, and effective.
BY LEN LANTZ, MD, author of unJoy / 3.29.24; No. 70 / 8 min read
Disclaimer: Yes, I am a physician, but I’m not your doctor, and this article does not create a doctor-patient relationship. This article is for educational purposes and should not be seen as medical advice. You should consult with your physician before you rely on this information. This post also contains affiliate links. Please click this LINK for the full disclaimer.
I’ve been waiting years for this announcement
Yesterday, my email inbox pinged with a message that the FDA finally approved Transcranial Magnetic Stimulation (TMS or rTMS) for adolescent depression. I was on cloud nine all day over this amazing, wonderful news. The world had been sitting on over 15 years of research on treating adolescent depression with TMS, and I had been growing increasingly impatient. In fact, I had been so frustrated with the FDA over their lack of action in approving TMS for kids that in 2022 I wrote an advocacy article titled, “Action Needed from the FDA: Approval to Treat Adolescent Depression with Transcranial Magnetic Stimulation (TMS).”
Well, the FDA’s recent decision changed everything. I was thrilled to be able to archive that advocacy article today, because the FDA finally took action. Researchers, staff at Neuronetics (the manufacturer of the NeuroStar TMS device), and professionals at the FDA all deserve major kudos for this approval.
FDA approval of TMS therapy for adolescent depression has been the most important step forward for depressed kids and their families in the past 15 years.
Why would I say that? Well, for starters, there are currently still only two antidepressants that are FDA-approved for depression in kids:
Prozac (fluoxetine): approved in 1987 for ages 8 and older
Lexapro (escitalopram): approved in 2009 for ages 12 and older
While several other antidepressant medications have been researched and shown to be safe and effective in treating adolescent depression, the FDA has not taken action to approve them for youth. I have found the FDA’s inaction to be so frustrating that in 2020 I wrote an opinion piece, “The FDA’s Duty to Children’s Mental Health.”
The more invasive treatment of electroconvulsive therapy (ECT) exists as a treatment option for adolescents with severe, treatment-resistant depression. ECT, which was approved by the FDA for adolescents in 2018, treats depression by causing a short seizure in the brain (the patient is under anesthesia during treatment) a few times per week over a few weeks. While ECT is very effective, adolescent patients whom I have previously referred for ECT were denied access to the treatment either by the ECT providers or their insurance companies. Additionally, ECT is costly, associated with cognitive side effects, and not available in many communities.
Lastly, while evidence-based psychotherapy, such as cognitive behavioral therapy (CBT), is frequently very effective for adolescent depression, not all patients respond to this, and we simply need more FDA-approved treatments for childhood depression.
What is TMS therapy?
Transcranial Magnetic Stimulation (TMS) therapy is one of the most effective and newest treatments for major depression, especially treatment-resistant depression. TMS does not cause a seizure. It works by delivering hundreds of magnetic pulses during a treatment session over the left front scalp. The pulses stimulate the area of the brain known as the DLPFC (dorsolateral prefrontal cortex), which is underactive in depression (Baxter, et al. Arch Gen Psychiatry. 1989). TMS lifts depression by stimulating that area of the brain (Schutter. Psychological Medicine. 2009).
TMS therapy was first approved by the FDA for the treatment of refractory depression in 2008 for people ages 22-70, and it is now widely used for people aged 18 and above.
TMS therapy is performed at a clinic with a skilled physician and trained staff. Treatment protocols vary from a traditional treatment course involving a 20-minute session once per day for 6 to 8 weeks (see my 2020 article, Transcranial Magnetic Stimulation (TMS) – the Best New Depression Treatment) to a newer treatment course requiring 10 treatment sessions per day for 5 days (see my 2021 article, A New Kind of TMS for Depression: SAINT Becomes Stanford Neuromodulation Therapy (SNT)). TMS has minimal side effects, and when depression improves, the improvement usually lasts.
The recent FDA approval of TMS therapy for adolescent depression provides a new level of hope for the parents and mental health providers of kids with depression.
There are many reasons for taking adolescent depression seriously
Kids with depression can experience many problems related to their illness. They can struggle a great deal in their relationships, school, and other important activities. Unfortunately, the rates of adolescent depression in the United States continue to climb (Racine, et al. JAMA Pediatrics. 2021).
Here’s the elephant in the room: Children are dying from depression-related suicide at an increasing and alarming rate in the United States (Curtin. NVSR. 2020). Depression is the strongest risk factor among people who die by suicide and has been shown to be the cause of up to 70% of suicides (Takahashi. JMAJ. 2001). Encouragingly, research shows that as adolescent depression improves with TMS therapy, so does suicidality (Croarkin, et al. J Affect Disord. 2018).
Treating depression effectively is one of the most strategic approaches to prevent suicide.
It is important to treat adolescent depression quickly and thoroughly. While it is nice to improve depression, the ultimate goal must be to help a depressed kid to become fully free from the depression, which is referred to as “remission.” If depression is treated until full remission, the outcomes are significantly improved, and the adolescent is less likely to slip back into depression when they face new stresses and disappointments in life. Also, the faster kids reach remission from their depression, the better the outcomes (Kratochvil, et al. JAACAP. 2006).
What the research shows regarding TMS for adolescent depression
There has been a growing accumulation of evidence on TMS therapy for adolescent depression. As you can see from the progression of research below, TMS for kids is safe, well-tolerated, and effective. While there are common, tolerable side effects to treatment, such as scalp discomfort or headache, serious side effects are rare. For example, an adverse reaction of a seizure during treatment from TMS is rare in kids, just as it is rare in adults.
Image: Research on TMS for Adolescent Depression by Len Lantz (CC BY-NC-ND)
That TMS is safe and effective for adolescent depression is also logical. TMS works amazingly well for depression in adults, so it should come as no surprise that it also is effective for kids.
Also, I can tell you from personal experience that TMS therapy is highly effective in treating depression. For over four years, my partner, Dr. Krista David, and I treated over 100 patients (three of whom were under age 18) with TMS for their severe depression. Based on standardized rating scales, we found that 75% of our patients saw substantial improvement in their depression with TMS. Results like this are astonishing as many of them had been depressed for decades (with no response to traditional therapies) before treatment with TMS.
What is unique about the new FDA approval
Several things make the FDA’s approval of TMS therapy for adolescents interesting and unique. The first is, of course, the age range of approval, which is for adolescents aged 15 and above. This is first the time the FDA has approved any TMS device – at this point, the approval is only for the NeuroStar TMS device – for anyone under age 22.
It is also interesting that the FDA approved TMS therapy for adolescent depression based on data not only from independent researchers but also on a dataset from TrakStar, which is NeuroStar’s internal, proprietary data collection platform. Neuronetics, the manufacturer of the NeuroStar TMS device, was able to dramatically increase the number of adolescent treatment outcomes (1,169 kids!) to show that 78% of depressed adolescents achieved meaningful clinically measured improvement in their depression symptoms with TMS. The company stated that “NeuroStar TMS was substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone in this population.” (Reference: NeuroStar Press Release)
While Neuronetics has provided scant details and has not released its dataset to the world, it is assumed that their depression improvement of 78% with NeuroStar TMS most likely represents a clinical “response” (50% or greater improvement in depressive symptoms) as opposed to “remission” (full freedom from depression).
On a side note, I find it very interesting that in the NeuroStar press release, they are using phrases of “First-Line Add-On” and “promising first-line treatment,” which might encourage investors but will only confuse mental health providers and patients. So, what did the FDA actually approve?
Here is the technical explanation: The NeuroStar TMS therapy device (as defined by FDA Sec. 882.5805) was cleared by the FDA on 3/22/24 as a “Substantially Equivalent (SESE)” device under 510(k) Number: K231926. Here is what that means in plain English:
The FDA has now approved NeuroStar TMS therapy for patients aged 15 and above with any severity of depression (mild, moderate, severe) after 1 failed antidepressant trial.
Managing health insurance delays and denials
Even though TMS therapy is now approved for ages 15 and above, people should not be surprised if their health insurance company is slow to respond. The “good” insurance companies will simply adjust their existing medical necessity criteria (the rules by which they approve a medical treatment) down to age 15. The “bad” companies will try to deny TMS for kids by calling it “experimental.” If you want to learn more about how they do this, feel free to read my article, “The Problem of Insurance Company Physicians Blocking Medical Care.”
TMS therapy for adolescent depression is a potentially life-saving treatment for kids. Now that the FDA has approved TMS for kids, insurance companies must provide coverage. If your health insurance company refuses to approve TMS for your child, they may be violating federal and state mental health parity laws. If you believe this is happening to your child’s care, I would encourage you to learn more by reading my article, “The Strengthening Behavioral Health Parity Act (SBHPA): An Enormous Step Forward in Mental Health Parity.”
Interestingly, now that FDA approval will ultimately force health insurance companies to cover TMS therapy for adolescent depression, the shift in insurance coverage will encourage even more TMS research in adolescent depression. That’s right! The FDA approval of TMS for adolescents will actually accelerate research in finding newer and even better solutions for adolescent depression.
TMS therapy for adolescent depression: a next step for treatment resistance
The professionals at the FDA got it right. Making TMS therapy available to depressed youth will improve the lives of thousands of kids and their families. This decision by the FDA will save many lives. There is now ample evidence proving that TMS for adolescent depression is safe, well-tolerated, and effective. The FDA’s decision gives new treatment options to kids and their families, and it will force health insurance companies to pay their fair share. There is realistic hope for kids with treatment-resistant depression. When traditional treatments fail, parents need to consider new strategies like TMS to help their children. Full freedom from depression is achievable, and it is what we want and need for all kids who struggle with depression.
For further reading, check out:
Len’s Article, “The Most Important New Findings in Depression”
Len’s Article, “The FDA’s Duty to Children’s Mental Health”
Len’s Article, “Transcranial Magnetic Stimulation (TMS) – the Best New Depression Treatment”
Len’s Article, “A New Kind of TMS for Depression: SAINT Becomes Stanford Neuromodulation Therapy (SNT)”
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