TMS for anxiety: cleared when anxiety comes with depression, off-label when it stands alone

Where the FDA line sits

Anxiety with depression versus anxiety alone

Every FDA clearance we reviewed that mentions anxiety uses nearly the same wording. BrainsWay’s reads: the device is indicated “for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.”

That sentence has three conditions: an adult, a diagnosis of major depressive disorder, and a current episode that did not respond well enough to antidepressants. Anxiety symptoms inside that picture are a cleared target. An anxiety disorder without major depression is not. The table below sets out how each situation stands.

FDA status is from the 510(k) summaries linked below (BrainsWay K210201, NeuroStar K220127, MagVenture K251119, Apollo K260560), read September 29, 2026. Devices are cleared, not approved: clearance means the FDA found the device substantially equivalent to one already on the market for the stated use.

Why it matters

What anxious depression is, and why it changes the treatment picture

Anxious depression means major depression with significant anxiety symptoms. It is not rare, and it tends to respond less well to antidepressants, which is part of why people with it end up asking about TMS.

Studies measure it in different ways. The STAR*D study, which enrolled 2,876 outpatients at 41 primary and psychiatric care sites, counted a patient as having anxious depression when the anxiety/somatization items of the Hamilton depression scale added up to 7 or more. By that measure, 53.2 percent of those starting citalopram had anxious depression. They were less likely to reach remission, took longer to get there, reported more side effects, and fared worse again when their medication was switched or augmented.

The newer DSM-5 “with anxious distress” label shows the same pattern. In a Dutch cohort of 1,080 people with major depression, 54.2 percent met it, and those who did had nearly double the odds of a chronic course over two years (odds ratio 1.96). The label predicted the course better than a separate anxiety disorder diagnosis did.

• A score of 7 or more on the Hamilton anxiety/somatization subscale: the definition used in STAR*D.
• The six-item Hamilton anxiety/somatization subscale: the anxiety measure in the TMS trials behind the FDA clearances.
• GAD-7 of 10 or more: the threshold for moderate anxiety in the NeuroStar registry data submitted to the FDA.
• The DSM-5 “with anxious distress” specifier: the label a psychiatrist may add to a depression diagnosis.

The cleared evidence

What the TMS trials measured for anxiety

The anxiety clearances did not come from new anxiety trials. The device makers went back to their depression trials, measured the change in the six anxiety items of the Hamilton scale, and compared active TMS with sham.

One finding in the BrainsWay reanalysis runs against the usual pattern: higher anxiety at the start predicted a better outcome with the H1 coil, while anxiety has predicted worse outcomes with medication. It is a company-authored result from pooled trial data and has not been tested in an independent prospective trial.

Off-label use

TMS for anxiety without depression: the evidence and its limits

For generalized anxiety disorder on its own, TMS has promising but thin evidence. The randomized trials are small, and the meta-analyses that combine them report large effects with warnings about how different the trials are.

• The first randomized sham-controlled trial for generalized anxiety disorder enrolled 25 people (13 active, 12 sham). Response and remission were higher with active TMS, using low-frequency stimulation over the right prefrontal cortex.
• A second trial treated 15 people with active and 25 with sham high-frequency TMS over the right prefrontal cortex. After 25 sessions, anxiety scores dropped much more with active treatment and held at 2 and 4 weeks; the authors named the small sample as a limit.
• A 2019 meta-analysis found 17 eligible studies across anxiety and trauma-related disorders: 9 in PTSD, 4 in generalized anxiety disorder, 2 in panic disorder, and 2 in specific phobia. It reported large effects for PTSD and generalized anxiety disorder and too few studies to judge panic disorder or phobia.
• A 2025 meta-analysis of 29 randomized trials found that adding TMS to medication lowered Hamilton anxiety scores by 3.38 points more than medication alone, and by 2.80 points more than sham TMS plus medication, with no serious adverse events. The authors asked readers to interpret this with caution because of high heterogeneity and a limited number of trials.

Notice where these studies aimed the coil. Both anxiety-only trials above stimulated the right side of the prefrontal cortex. The NeuroStar depression protocol behind its anxiety clearance stimulates the left. If a clinic offers TMS for anxiety alone, ask which side, which frequency, and which study the protocol comes from.

Insurance

How insurance decides on TMS when anxiety is part of the picture

Coverage runs through the depression diagnosis. Anxiety symptoms can improve during a covered depression course, but anxiety is not a separate coverage route in the policies below.

The Wisconsin Physicians Service Medicare policy L34641 (revision effective March 26, 2026) says outpatient TMS “may be indicated for patients with DSM-IV defined Major Depressive Disorder who have failed to benefit from initial treatment of their depression,” and that “all other uses of Transcranial Magnetic Stimulation are experimental and are not covered.” That is one regional Medicare contractor’s policy; other contractors and plans write their own, so ask for the policy that applies to you.

Aetna’s TMS policy (last reviewed July 17, 2026) requires an FDA-cleared device used within its labeled indication, a psychiatrist-confirmed diagnosis of severe major depression documented on a standardized rating scale, and, for adults, an inadequate response to two antidepressants from different classes and to an augmentation trial, each for at least 8 weeks. The same policy lists anxiety disorders, panic disorder, and PTSD among conditions for which the value of TMS has not been established.

• Ask the clinic to confirm the diagnosis it will bill: major depressive disorder, with the anxiety symptoms documented alongside it.
• Ask whether the prior authorization will include the depression rating scale and the medication history the plan requires.
• If anxiety is the main problem and depression is not diagnosed, ask for the self-pay price of the full course in writing before the first session.

Our TMS cost and insurance guide walks through pricing a full course and checking Medicare and commercial criteria.

Before the first session

Screening, side effects, and what else to read

The screening before TMS is the same whatever the reason for treatment: metal or implants near the head, seizure history, bipolar symptoms, and every medication. Our TMS side effects guide covers the published rates for scalp pain, headache, and seizure, and what feeling worse during a course means. The TMS overview covers how the treatment works, and the treatment-resistant depression hub covers the reassessment that should come before any brain-stimulation course.