Treatment-resistant depression is usually defined as a depressive episode that has not responded to at least two antidepressants given at an adequate dose for an adequate length of time. At that point the realistic options fall into six groups: optimize or change the medication, add an augmenting medication, add structured psychotherapy, use a brain stimulation treatment such as TMS or ECT, use esketamine or ketamine, or, for a small group with very long-standing illness, consider an implanted vagus nerve stimulator. Psilocybin is still investigational.
No single option is best for everyone. They differ in how strong the evidence is, how much time and disruption they involve, their side effects, and what insurers will pay for. This page lays them side by side, with the trial data behind each, so the conversation with your psychiatrist can be specific.
First, is it really treatment resistance?
The 2023 CANMAT depression guidelines note that there is no universally agreed definition of treatment-resistant depression (TRD), and that the common "two failed antidepressants" definition ignores psychotherapy and brain stimulation and leaves "failure" undefined. A 2023 review in World Psychiatry estimated that at least 30% of people with depression meet that definition, and that a significant share of them are "pseudo-resistant": the earlier trials were too short, the dose too low, or the medication was not taken consistently.
CANMAT's first step after a poor response is therefore not a new treatment but a reassessment: re-evaluate the diagnosis (a missed bipolar disorder is the example it gives), look for comorbid conditions such as anxiety disorders, ADHD, PTSD, substance use and sleep apnea, check adherence, and consider laboratory tests for medical contributors. Two companion articles cover this in detail: the medical workup for apparent treatment resistance and what pharmacogenomic testing can and cannot tell you.
The expectation to set comes from STAR*D, a large sequential medication study: remission rates were 36.8% and 30.6% at the first two steps, then 13.7% and 13.0% at the third and fourth. A 2023 reanalysis using the protocol's original blinded scale put cumulative remission at 35% rather than the published 67%, a conclusion the original investigators dispute. Either way, the yield of simply trying another antidepressant falls sharply after the second attempt, which is the argument for moving to a different kind of treatment. What STAR*D does and does not show is discussed separately.
Every option at a glance
| Option | Regulatory status for depression | What the best evidence shows | Burden | Main drawbacks |
|---|---|---|---|---|
| Switch antidepressant | Prescription drugs | 22.3% remission after switching to bupropion in VA patients (VAST-D); returns diminish after the second trial | Low; weeks to judge | Lowest yield in head-to-head trials |
| Augment with aripiprazole or a similar agent | Prescription drugs | 28.9% remission vs 22.3% for switching (VAST-D) | Low; a daily pill | Akathisia, weight gain, somnolence |
| Augment with lithium | Off-label for unipolar depression | Odds ratio 2.89 for response vs placebo across 9 small trials (237 patients) | Blood levels, kidney and thyroid monitoring | Old, small trials; narrow dosing range |
| Add CBT | Not applicable | 46% vs 22% response at 6 months when added to usual care (CoBalT) | Weekly sessions over months | Access; slower onset |
| TMS (standard rTMS or iTBS) | FDA-cleared devices | Beats sham in pivotal trials; CANMAT first line for TRD | Daily visits for about 6 weeks; no anesthesia | Time commitment; scalp discomfort and headache; rare seizure |
| Accelerated TMS | Some protocols FDA-cleared | Large effect in one small sham-controlled trial (29 treated) | Several sessions a day for days | Small evidence base; Aetna and Cigna class it as investigational |
| Esketamine (Spravato) | FDA-approved drug for TRD | 27.1% vs 17.6% remission at week 8 against quetiapine augmentation (ESCAPE-TRD) | Clinic visits with 2 hours of monitoring; no driving until the next day | Dissociation, blood pressure rises, open-ended maintenance |
| IV ketamine | Off-label; not FDA-approved for any psychiatric disorder | Non-inferior to ECT on a self-rated scale in non-psychotic TRD (ELEKT-D) | Infusion visits with monitoring | Durability; no approved label or standard protocol |
| ECT | Established procedure | Response rates of 65% to 75%; most effective overall, especially in psychotic depression | 6 to 12 sessions under general anesthesia | Memory effects; relapse is common even with continuation treatment |
| Vagus nerve stimulation | FDA premarket approval (2005) after four or more failed treatments | 12-month RECOVER trial missed its primary endpoint; several secondary outcomes favored active stimulation | Surgical implant; benefit builds over months | Surgery; Medicare covers it only inside approved studies |
| Psilocybin | Investigational; not FDA-approved | Mixed results in published phase 2 trials; one 2026 trial missed its primary endpoint | Research settings only | Not legally available as a treatment; durability uncertain |
The percentages in this table come from different trials with different patients, scales and definitions. They show what each study found; they are not a league table, and they should not be read across rows.
Medication strategies: optimize, switch or augment
CANMAT lists the medication moves in order: optimize the dose of the current antidepressant, then either switch to another or add an adjunctive medication. It notes that meta-analyses have not shown switching to be better than continuing the same drug, that head-to-head trials favor adjunctive strategies, and it recommends considering adjunctive strategies earlier.
Three large trials shape that advice. In VAST-D (2017), 1,522 veterans whose depression had not responded to at least one antidepressant were randomized to switch to bupropion, add bupropion, or add aripiprazole; remission at 12 weeks was 22.3%, 26.9% and 28.9% respectively, and only aripiprazole augmentation was statistically better than switching. The authors called the advantage modest and pointed to more somnolence, akathisia and weight gain with aripiprazole. In OPTIMUM (2023), a similar comparison in 619 adults aged 60 and older, remission occurred in 28.9% with aripiprazole augmentation, 28.2% with bupropion augmentation and 19.3% with a switch to bupropion.
The third trial matters for anyone weighing TMS. ASCERTAIN-TRD (2024) randomized 278 people with treatment-resistant depression to add aripiprazole, add rTMS, or switch to venlafaxine or duloxetine for 8 weeks. On the primary depression scale, adding rTMS was superior to switching; adding aripiprazole was not. It was open-label, so expectation effects cannot be excluded, but it tests TMS directly against the usual medication moves in a randomized design.
Which augmenting agents
Among adjunctive medications, CANMAT gives low-dose atypical antipsychotics the most consistent evidence. It lists aripiprazole and brexpiprazole as first-line adjuncts, cariprazine as second line because there are fewer studies, and olanzapine, quetiapine XR and risperidone as second line because of weight, metabolic, sedation or hormonal side effects. Adding a second antidepressant such as mirtazapine or bupropion is also second line.
Lithium and thyroid hormone (T3) remain second-line adjuncts in CANMAT. The guideline is frank that the trials it relied on predate 2003, were small and involved adjunctive use with tricyclic antidepressants only. A 2014 meta-analysis of nine placebo-controlled trials (237 patients) found an odds ratio for response of 2.89 with lithium versus placebo, with benefit seen alongside both tricyclic and second-generation antidepressants. In OPTIMUM's second step, lithium augmentation and a switch to nortriptyline produced similar remission rates of 18.9% and 21.5%. Lithium requires blood levels and periodic kidney, calcium and thyroid tests. The site's medication management page describes how medication decisions are approached in this practice generally.
Psychotherapy as a next step, not a consolation prize
Psychotherapy is often left out of TRD discussions, and the evidence says it should not be. In the CoBalT trial (2013), 469 primary care patients who had not responded to at least six weeks of an antidepressant were randomized to usual care or usual care plus cognitive behavioral therapy. At six months, 46% of the CBT group had responded versus 22% with usual care alone. On that basis CANMAT recommends CBT as a second-line adjunctive treatment alongside medication for difficult-to-treat depression.
Some payers build psychotherapy into their rules. New York Medicare and Cigna both require a failed trial of evidence-based psychotherapy before they will cover TMS. The practice's psychotherapy page and its guide to choosing a therapy for depression go further.
Brain stimulation: TMS, ECT and VNS
TMS and its variants
TMS delivers magnetic pulses to the left dorsolateral prefrontal cortex in outpatient sessions, without anesthesia. CANMAT rates rTMS for treatment-resistant depression as first line with Level 1 evidence for acute efficacy, while noting that in practice it is usually offered after first-line medication and psychotherapy because of access. The VA/DoD guideline is more cautious, giving a "weak for" recommendation after two or more adequate medication trials. The 2010 APA guideline says TMS "could also be considered" after medication non-response, a moderate-confidence recommendation.
The honest size of the effect: in the NIMH-funded OPT-TMS trial, 14.1% remitted with active TMS versus 5.1% with sham. Open-label clinic figures are far higher, with 58% clinician-rated response and 37.1% remission in a 42-practice US study, but there was no sham group and sham response in TMS trials is large. How TMS success is measured explains why these numbers differ.
Variants change the logistics more than the principle:
- Intermittent theta burst (iTBS) shortens a session to about 3 minutes and was non-inferior to standard 10 Hz stimulation in the 414-patient THREE-D trial. See theta burst stimulation explained.
- Deep TMS uses a different coil (the H1 coil); in its pivotal trial, intention-to-treat remission was 30.4% versus 15.8% with sham.
- Accelerated protocols deliver several sessions a day. In the only sham-controlled SAINT trial, 11 of 14 patients remitted with active treatment versus 2 of 15 with sham, but the trial was small, single-site and stopped early. Accelerated TMS has its own page.
Side effects are mostly scalp discomfort and headache; in the NeuroStar program 4.5% of patients stopped because of adverse events. Seizure is rare, estimated at fewer than 1 per 60,000 sessions when guidelines are followed in people without risk factors. Among people who respond, studies suggest roughly half to about 6 in 10 are still doing well at one year.
TMS is not the right first step for psychotic depression or acute suicidal crisis, where expert consensus points to treatments with established efficacy such as ECT.
Electroconvulsive therapy (ECT)
Electroconvulsive therapy remains the most effective acute treatment. The APA guideline says it "remains the most effective form of therapy and should be considered" for depression that has not responded to medication. CANMAT cites response rates of 65% to 75% over a course of 6 to 12 sessions, each under general anesthesia. In head-to-head meta-analyses ECT outperformed rTMS overall (remission 52.9% versus 33.6% in one), with the advantage clearest in psychotic depression.
The costs are real. A study of 347 patients treated in New York City-area facilities found cognitive effects still detectable six months later, worse with bilateral electrode placement. Relapse is common: in the CORE continuation trial, 37.1% relapsed within six months on continuation ECT and 31.6% on lithium plus nortriptyline. The VA/DoD guideline gives ECT a "strong for" recommendation in severe depression with catatonia, psychosis or severe suicidality. TMS vs ECT compares the two in detail.
If you are thinking about suicide or are in crisis, call or text 988 (the 988 Suicide & Crisis Lifeline) or go to the nearest emergency room.
Vagus nerve stimulation
Vagus nerve stimulation (VNS) uses a pulse generator implanted in the chest that stimulates the left vagus nerve in the neck. It received FDA premarket approval in July 2005 as an adjunctive long-term treatment for chronic or recurrent depression in adults who have not responded to four or more adequate antidepressant treatments. CANMAT rates it third line.
The RECOVER trial (493 adults with at least four failed treatments in the current episode, and an average of 13.3 lifetime antidepressant treatments) compared active with sham stimulation over 12 months. Its prespecified primary outcome did not separate the groups, although several secondary measures of symptoms, function and quality of life favored active stimulation. Medicare covers VNS for depression only within CMS-approved studies and does not cover it outside them. VNS also matters for a practical reason: an implanted vagus nerve stimulator is listed as a contraindication in FDA's TMS guidance.
Esketamine, ketamine and psilocybin
Esketamine and ketamine
Esketamine nasal spray (Spravato) is FDA-approved for treatment-resistant depression in adults, as monotherapy or with an oral antidepressant. In ESCAPE-TRD (2023), 676 patients were randomized to esketamine or extended-release quetiapine, each added to an SSRI or SNRI; 27.1% versus 17.6% were in remission at week 8. It is given only in certified clinics, with at least two hours of monitoring after each dose. CANMAT places both intranasal esketamine and adjunctive IV ketamine at second line because of side effect potential and feasibility issues.
IV ketamine is a different legal category. FDA states that ketamine is not approved for any psychiatric disorder, so its use for depression is off-label. In ELEKT-D (2023), 403 patients with non-psychotic TRD were randomized to ketamine infusions or ECT for three weeks; self-rated response was 55.4% versus 41.2%, meeting the test for non-inferiority, with less memory impairment in the ketamine group. That is not the same as showing ketamine beats ECT, and the trial excluded psychotic depression. The detailed comparison is in TMS vs Spravato; the practice's own approach to ketamine is on its ketamine-assisted psychotherapy page.
Psilocybin: where the research stands
Psilocybin is not an available treatment. CANMAT classes psilocybin-assisted psychotherapy as investigational, citing problems with blinding, expectancy and a lack of long-term safety data. In the largest published phase 2 trial (233 participants, NEJM 2022), a single 25 mg dose reduced depression scores by 6.6 points more than a 1 mg control dose at three weeks, but sustained response at 12 weeks was not clearly supported, and suicidal ideation or self-injury occurred in all dose groups. In the EPISODE trial (JAMA Psychiatry 2026; 144 participants), response at week 6 was 17.0% with 25 mg and 10.6% with an active placebo, a difference that was not statistically significant.
In April 2026 the developer of one synthetic psilocybin formulation announced that FDA had agreed to a rolling review of its application and said its two phase 3 trials had produced positive data; those are company statements, and the product remained investigational at that point. Until FDA acts, psilocybin is not an approved medical treatment for depression in the United States, and a clinical trial is the appropriate way to receive it.
How the options rank against each other
Direct comparisons are scarce, so researchers use network meta-analysis, which chains trials together statistically. One published in 2025 pooled 69 randomized trials (10,285 participants who had not responded to at least two antidepressants) and found six treatments with higher response rates than placebo or sham: ECT, minocycline, theta burst stimulation, rTMS, ketamine and aripiprazole, with odds ratios from 1.9 for aripiprazole to 12.86 for ECT. A separate 2025 network meta-analysis of 35 trials found no significant difference in response or remission among ECT, rTMS and IV ketamine and rated its own confidence as very low.
Read together, these say three things. Brain stimulation and ketamine-class treatments have the most support at the two-failure stage. ECT has the largest effect and the largest burden. And the evidence is not strong enough to rank the middle of the field with confidence, which is why individual factors decide.
What insurers typically require
Coverage rules often determine the order in which options are tried. For TMS, most plans require documented medication failures in the current episode:
- New York Medicare: no clinically significant response to one medication trial using agents from at least two different classes (or one of a few listed alternatives), plus a trial of evidence-based psychotherapy.
- New York Medicaid: two trials of two different antidepressants at a therapeutic dose.
- Aetna: two antidepressants from two classes for at least 8 weeks each, plus an 8-week augmentation trial.
- Optum (UnitedHealthcare): two medication regimens from two classes, with no psychotherapy requirement.
Maintenance TMS is generally not covered, and accelerated protocols are classed as investigational by Aetna and Cigna. Plan-by-plan details are in the coverage series, starting with Medicare TMS coverage in New York and Aetna's criteria. Esketamine, ECT and VNS each have separate rules that your plan can confirm.
Putting it in order
A reasonable sequence for most adults with non-psychotic depression, consistent with the guidelines above, looks like this:
- Confirm the diagnosis, adherence, dose and duration, and look for medical and psychiatric contributors.
- Optimize the current antidepressant; add evidence-based psychotherapy if it has not been tried.
- After two adequate medication trials, weigh augmentation, TMS and esketamine side by side rather than defaulting to a third antidepressant.
- Move to ECT sooner when depression is severe, psychotic, catatonic or life-threatening.
- Reserve VNS for long-standing illness after four or more failed treatments, and treat psilocybin as research.
The sequence bends for individuals. CANMAT notes rTMS can be a first choice when medication tolerability is the problem or when it worked in a previous episode. Someone who cannot attend daily visits may be better served by augmentation or esketamine. Someone with significant side effects from every medication tried may reasonably prefer a non-drug treatment. Combining TMS with medication covers what is known about using both.
The rest of this series is collected in the TMS guide, and the practice's current TMS information is on the TMS service page. For a plain-language starting point, the sister site's article on what treatment-resistant depression means is a good first read.
Frequently asked questions
How many antidepressants do you have to try before depression is called treatment-resistant?
The most common definition is two antidepressants, each at an adequate dose for an adequate duration, without a satisfactory response. There is no universally agreed definition, and insurers apply their own versions when deciding on coverage.
Is it better to switch antidepressants or add a second medication?
In the large head-to-head trials, adding aripiprazole produced somewhat higher remission rates than switching to another antidepressant, at the cost of more side effects such as restlessness and weight gain. Guidelines now suggest considering add-on strategies earlier, but the differences are modest and side effects matter.
Is ECT more effective than TMS?
Overall, yes, particularly for psychotic depression. ECT also requires general anesthesia and carries a risk of memory problems, which is why guidelines generally suggest considering TMS first unless the situation is urgent.
Can I get psilocybin therapy for depression now?
Not as an approved treatment. Psilocybin remains investigational in the United States and is available legally for depression only through clinical trials.
What if TMS does not work for me?
The other options remain open. Esketamine, augmentation, ECT and psychotherapy work through different mechanisms, and not responding to one does not predict failure with another. Your psychiatrist should also revisit the diagnosis and any medical contributors.
Does treatment-resistant mean my depression cannot be treated?
No. The term describes what has been tried so far, not what is possible. Many guideline authors now prefer 'difficult-to-treat depression' for exactly this reason.
Sources
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Educational information, not medical advice. Whether TMS or any treatment fits you is a decision to make with a psychiatrist who knows your history.
The information provided on this blog is for educational and informational purposes only. It is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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