Deep TMS is FDA-cleared for anxious depression, meaning major depressive disorder with significant comorbid anxiety. The standard 36-session depression protocol reduces both depression and anxiety scores in pooled trial data. TMS is not cleared for generalized anxiety disorder or other anxiety disorders on their own, and insurers do not cover it for anxiety without depression. Stedfast offers it at Palm Beach Gardens.
In 2021 the FDA cleared Deep TMS for anxious depression, based on pooled trial data showing that the standard depression protocol reduced anxiety symptoms along with depressive ones. This page explains what the clearance covers, what it does not cover, and how we use Deep TMS at Palm Beach Gardens for patients whose depression comes with worry, tension and panic.
Who it is for
The ideal candidate has major depressive disorder as the primary diagnosis, with anxiety symptoms that are prominent enough to show up on a scale like the GAD-7 or the HAM-A, and has not responded adequately to antidepressants. In practice this describes most of the treatment-resistant patients we see. People whose anxiety takes the form of generalized worry, restlessness, tension, panic attacks or irritability all fall within the clearance as long as depression is present. People with an anxiety disorder but no depression do not currently qualify, either clinically under the clearance or for insurance coverage. Patients who have been on benzodiazepines long-term are candidates, but high doses can blunt TMS response and we may suggest a gradual reduction.
How it works
Anxious depression does not get a separate protocol. The treatment is the standard Deep TMS depression course: 18 Hz stimulation of the left dorsolateral prefrontal cortex, five days a week for six weeks with a taper, 36 sessions in total. The clearance was granted because an analysis of pooled data from Deep TMS depression trials showed that patients with comorbid anxiety improved as much as those without, and that their anxiety scores fell in parallel with their depression scores. The likely explanation is that the prefrontal circuit TMS strengthens is involved in regulating the amygdala and the stress response, so increasing prefrontal activity reduces both the low mood and the hyperarousal. Anxiety and depression share more neurobiology than their separate names suggest.
The FDA cleared Deep TMS for anxious depression in 2021, defined as major depressive disorder with comorbid anxiety symptoms, based on pooled analysis of trial data.
Source: FDA 510(k) K210201, 2021
In the pooled analysis supporting the clearance, patients with anxious depression showed a mean reduction of about 10 points on the Hamilton Anxiety Rating Scale with active Deep TMS, significantly greater than sham, alongside their depression improvement.
Source: Pell et al., Journal of Affective Disorders, 2022
About 60 to 90 percent of patients with major depressive disorder have clinically significant anxiety symptoms, and roughly half meet criteria for a comorbid anxiety disorder.
Source: Kessler et al., National Comorbidity Survey Replication, Archives of General Psychiatry, 2005; Fava et al., STAR*D, Psychological Medicine, 2008
In STAR*D, patients with anxious depression had lower remission rates and more side effects on citalopram than non-anxious patients, 22 versus 33 percent remission.
Source: Fava et al., American Journal of Psychiatry, 2008
What to expect
Your course looks the same as a depression course, with one difference: we track anxiety as well as depression. You will complete the GAD-7 or HAM-A alongside the PHQ-9 at baseline and at least every two weeks. Some anxious patients notice a brief increase in restlessness or trouble sleeping during the first week, which usually settles; scheduling afternoon rather than evening sessions helps. Most patients report that the physical tension and the sense of dread lift around the same time as the mood improves, in weeks three to five. Panic attacks often become less frequent before they stop entirely.
Benefits
- One course treats both depression and anxiety symptoms
- No sedation, no dependence and no withdrawal, unlike benzodiazepines
- No activation or jitteriness in the first weeks, a common problem when starting SSRIs in anxious patients
- Covered by insurers under the depression diagnosis
- Can be combined with therapy for anxiety, such as CBT or exposure work
Risks and side effects
Side effects are the same as for any Deep TMS depression course: scalp discomfort and headache in the first week, facial twitching during pulses, rare seizure risk under 0.1 percent per course. Anxious patients are more likely to find the first session unsettling because of the noise and sensation, and we take extra time on day one to explain each step. A small number of patients report transient increased anxiety or insomnia in week one. There are no cognitive, sexual or weight effects.
Cost and insurance
Anxious depression is billed and authorized as major depressive disorder, so coverage follows the depression rules: Medicare covers TMS in Florida when criteria are met, and most commercial plans cover it after two to four failed antidepressant trials with PHQ-9 or HAM-D documentation and prior authorization. There is no separate coverage pathway for anxiety, and TMS for an anxiety disorder without depression is not covered. For self-pay, ask our TMS coordinator for current self-pay rates.
Why anxious depression is harder to treat
The STAR*D trial looked at this directly. Patients whose depression came with high anxiety had a remission rate of about 22 percent on citalopram, compared with 33 percent for non-anxious patients, and they dropped out more often because of side effects. The pattern held at every subsequent treatment step. Anxious patients are more sensitive to the early activation that SSRIs and SNRIs cause, more likely to be prescribed benzodiazepines that bring their own problems, and more likely to relapse after improvement. A treatment that does not cause activation and that acts on the shared circuitry of mood and anxiety has obvious appeal.
The evidence behind the clearance
The 2021 clearance rested on a pooled analysis of patients from Deep TMS depression trials who met criteria for anxious depression, published by Pell and colleagues in the Journal of Affective Disorders in 2022. In that analysis, active Deep TMS reduced Hamilton Anxiety Rating Scale scores by about 10 points, significantly more than sham, and the depression response rate in anxious patients was no lower than in non-anxious patients. In other words, the anxiety that makes medication less effective did not make TMS less effective. Separate figure-8 rTMS data show the same pattern, and several figure-8 systems have since received the same clearance.
What the clearance does and does not cover
| Situation | Within the clearance? | Insurance coverage? |
|---|---|---|
| Major depression with generalized worry and tension | Yes | Yes, under MDD criteria |
| Major depression with panic attacks | Yes | Yes, under MDD criteria |
| Major depression with comorbid GAD, social anxiety or PTSD | Yes, for the depression and its anxiety symptoms | Yes, under MDD criteria |
| Generalized anxiety disorder without depression | No | No |
| Panic disorder without depression | No | No |
| PTSD without depression | No; research protocols only | No |
| OCD | Yes, under a separate 2018 clearance with the H7 coil | Plan-dependent |
TMS for anxiety disorders alone: where the research stands
You will find clinics advertising TMS for anxiety, PTSD and panic without qualification. The research is active and some results are encouraging. Low-frequency stimulation of the right prefrontal cortex has shown benefit in small trials of generalized anxiety disorder. Several PTSD trials have reported symptom reduction, and the Department of Veterans Affairs has studied TMS for PTSD extensively with mixed results. None of this has reached the standard of a large sham-controlled trial leading to clearance, and insurers treat it as investigational. We tell patients this plainly. If you have an anxiety disorder without depression, we will treat it with the options that have strong evidence and keep TMS in view as the research matures.
Combining TMS with therapy for anxiety
TMS reduces symptoms but does not teach the skills that keep anxiety from returning. We encourage patients in a TMS course to continue or begin cognitive behavioral therapy, and for panic or phobic symptoms, exposure-based therapy. Patients often report that exposures feel more manageable during and after TMS, which is consistent with the idea that a better-regulated prefrontal cortex makes it easier to tolerate distress without avoidance. Stedfast provides psychotherapy at all of our offices and by telehealth, so therapy can continue at the office nearest you while TMS sessions happen at Palm Beach Gardens.
Medication during an anxious depression course
Continue your antidepressant. If you take a benzodiazepine, discuss the dose with your prescriber; doses above about 2 mg of lorazepam equivalent per day have been associated with weaker TMS response in some studies, and a gradual reduction before or during the course may improve results. Do not stop benzodiazepines abruptly. Buspirone, hydroxyzine and propranolol do not interfere with TMS and can be continued.
Deep TMS in Palm Beach Gardens
Stedfast Psychiatry delivers Deep TMS at our Palm Beach Gardens office, 11641 Kew Gardens Ave, Suite 209, just off PGA Boulevard and I-95. Patients travel to us from Jupiter, West Palm Beach, Boynton Beach, Stuart and Royal Palm Beach, and most find the drive manageable because a Deep TMS session takes about 20 minutes and you drive yourself home. Call (561) 437-2199 to schedule a TMS consultation, or ask your current Stedfast provider for an internal referral. Our TMS coordinator handles insurance verification, prior authorization and scheduling so you can start as soon as approval comes through.
Frequently asked questions
Does TMS work for anxiety?
For anxiety that accompanies depression, yes: Deep TMS is FDA-cleared for anxious depression and pooled trial data show anxiety scores fall alongside depression scores. For anxiety disorders without depression, the evidence is promising but preliminary, there is no FDA clearance, and insurers do not cover it. If you have generalized anxiety, panic disorder or social anxiety and no depression, medication and cognitive behavioral therapy remain the first-line treatments.
What is anxious depression?
It is major depressive disorder with prominent anxiety symptoms: persistent worry, restlessness, muscle tension, feeling keyed up, trouble concentrating because of worry, or panic attacks. The DSM-5 uses the specifier with anxious distress. It is the most common form of depression, affecting more than half of patients, and it responds less well to antidepressants than depression without anxiety, which is why a treatment that addresses both is valuable.
Is the TMS protocol different for anxious depression?
No. The clearance applies to the standard Deep TMS depression protocol: 18 Hz stimulation of the left prefrontal cortex, 36 sessions over six to nine weeks. What differs is the monitoring; we track anxiety with the GAD-7 or HAM-A in addition to the depression scales. Research protocols that target the right prefrontal cortex with low-frequency stimulation specifically for anxiety exist but are not cleared and are not what we offer.
Can TMS help me get off benzodiazepines?
Indirectly. TMS does not treat benzodiazepine dependence, but as depression and anxiety improve, many patients find they need less. High-dose benzodiazepines may also blunt TMS response, so we often recommend a gradual reduction before or during the course, coordinated by your prescriber. Never stop a benzodiazepine abruptly; withdrawal can cause seizures, which is also a TMS safety concern.
Will TMS make my anxiety worse at first?
Occasionally and briefly. A small number of patients report increased restlessness or trouble sleeping in the first week, likely from the novelty of the sessions and the activating effect of prefrontal stimulation. It usually settles by week two. Scheduling morning or early afternoon sessions, avoiding caffeine before treatment, and using the rest intervals to practice slow breathing all help. Unlike SSRIs, TMS does not cause the weeks of jitteriness that anxious patients often experience when starting medication.
Does TMS help with panic attacks?
In patients with anxious depression, panic attack frequency commonly falls as the course progresses, often before the attacks stop entirely. Panic disorder on its own is not a cleared indication and has only small studies behind it. If panic is your primary problem and depression is mild or absent, cognitive behavioral therapy with interoceptive exposure and an SSRI are the treatments with the strongest evidence.
Does insurance cover TMS for anxiety?
Not as a standalone diagnosis. Coverage runs through the major depressive disorder diagnosis, which most anxious patients also meet. If you have depression with anxiety and meet the medication-trial and severity criteria, Medicare and most commercial plans cover the course. If you have only an anxiety disorder, no insurer currently covers TMS for it, and we would recommend other treatments before considering self-pay TMS.
Where this treatment is offered
Conditions this treats
If you are in crisis, call or text 988 or go to the nearest emergency room. Educational content; individual results vary. Reviewed by Dr. David Husted, board-certified psychiatrist.