SAINT® vs Psilocybin Therapy for Treatment-Resistant Depression

If you are comparing SAINT® and psilocybin therapy, you are comparing two different approaches to treatment-resistant depression — depression that has not improved enough after trying at least one antidepressant. They work through different mechanisms, have different regulatory statuses, and are available in different places. Understanding those differences helps you make an informed choice.

SAINT® (Stanford Accelerated Intelligent Neuromodulation Therapy) is delivered on the Magnus Medical SAINT Neuromodulation System. It uses a functional MRI (fMRI) scan to personalize the treatment target for each person, then delivers 10 sessions per day over 5 consecutive days — about 50 sessions total. It is FDA-cleared for major depressive disorder (MDD) in adults whose depression has not improved enough on prior antidepressant medication. Neuro Wellness treats adults 22 and older.

Psilocybin therapy combines the psychedelic compound psilocybin — derived from certain mushrooms — with psychotherapy. Psilocybin acts on serotonin receptors in the brain. It is not FDA-approved for depression or any other condition. It remains a Schedule I controlled substance under federal law. Legal therapeutic access is currently limited to state-regulated programs in Oregon and Colorado. Neuro Wellness does not offer psilocybin therapy.

Both are legitimate areas of active research. The question is which fits your diagnosis, where you live, and what level of regulatory oversight and evidence you want behind your treatment. Learn more about SAINT® and take the free candidacy screener to see which FDA-cleared options may apply to you.

Psilocybin is a naturally occurring psychedelic compound found in certain species of mushrooms. In clinical research, it is being studied as a potential treatment for depression, often combined with psychotherapy in what is called psilocybin-assisted therapy or psilocybin therapy. The compound acts primarily on serotonin 5-HT2A receptors in the brain, which are involved in mood, perception, and cognition.

Psilocybin is not FDA-approved for depression or any other condition. The FDA has designated psilocybin as a Breakthrough Therapy for treatment-resistant depression, which can expedite the development and review process, but a Breakthrough Therapy designation is not the same as approval. No psilocybin-containing product has received FDA approval for clinical use in depression treatment.

Under federal law, psilocybin is a Schedule I controlled substance, meaning it is classified as having a high potential for abuse and no currently accepted medical use. Legal therapeutic access is currently limited to state-regulated programs. Oregon and Colorado have established frameworks for regulated psilocybin use. Psilocybin therapy is not legally available in Florida or most other states. Neuro Wellness does not offer psilocybin therapy and does not provide referrals for it.

SAINT®, by contrast, is FDA-cleared as a complete system. The Magnus Medical SAINT Neuromodulation System received 510(k) clearance (K220177) and a Breakthrough Device designation specifically for the SAINT® protocol, including the fMRI-guided targeting software. It is legally available at verified providers, including Neuro Wellness in Coral Springs, Florida. For more on what treatment-resistant depression means, see our treatment-resistant depression guide.

The evidence base for SAINT® and psilocybin differs in design, regulatory stage, and availability. SAINT® has published randomized controlled trial (RCT) data for the SAINT® protocol on the Magnus system. Psilocybin has shown promise in early-phase clinical trials for depression, but it has not completed the full FDA approval process and is not available as an approved treatment.

In the 2022 randomized trial, 79% of participants reached remission (Cole et al., Am J Psychiatry 2022;179(2):132–141). Individual results may vary. That figure comes from the SAINT® trial and applies to the SAINT® protocol on the Magnus system — it does not transfer to psilocybin therapy, standard TMS, or any other treatment.

Psilocybin research has reported reductions in depression scores in small, carefully controlled clinical studies, often with a limited number of dosing sessions paired with psychotherapy. These studies are promising but early-stage, and the sample sizes are typically small. Because psilocybin is not FDA-approved, there are no large-scale, post-approval real-world outcome datasets comparable to what exists for FDA-cleared treatments. Ask any provider offering psilocybin therapy for its own published outcome data.

For a deeper look at SAINT® remission and response data, see our SAINT® TMS success rates page.

SAINT® and psilocybin therapy differ in what the treatment experience is like, how long it takes, and what it costs.

SAINT® is non-invasive. There is no anesthesia, no sedation, and no hospital stay. You sit in a chair while a coil placed on your scalp delivers magnetic pulses. The full course is 5 consecutive days, with 10 sessions per day. You are in the clinic for most of the day during treatment week, but the course is over in one week. Neuro Wellness is a Verified SAINT® Provider in Coral Springs, Florida.

Psilocybin therapy involves ingesting a psychedelic compound during a supervised dosing session, typically paired with preparatory and integration psychotherapy sessions. The full course is spread over weeks or months. Because psilocybin is not FDA-approved and remains a Schedule I substance, it is not legally available in Florida. Neuro Wellness does not offer psilocybin therapy.

On cost: SAINT® at Neuro Wellness starts at $25,000. That price reflects the fMRI scan, the FDA-cleared targeting software, the Magnus system, physician oversight, and the full 50-session week. SAINT® may be covered by insurance; coverage varies by plan. We verify your benefits for free, whatever carrier you have, so you know what your plan allows before you commit. Financing is available on a case-by-case basis and is discussed during your consultation. Psilocybin therapy costs vary by state-regulated program and are not offered at or covered through Neuro Wellness.

For the full SAINT® cost breakdown, see our SAINT® TMS cost page. To check what your plan covers, start with a free benefits verification.

SAINT® fits adults with major depressive disorder whose depression has not improved enough on prior antidepressant medication and who can commit to 5 consecutive days in the clinic. The compressed schedule suits people who want to avoid weeks of daily visits and who want a protocol with fMRI-guided personalized targeting and published randomized trial data. It is not for people with non-removable magnetic-sensitive metal near the head, certain implanted devices, or increased intracranial pressure.

Psilocybin therapy may appeal to adults who are interested in a psychedelic-assisted approach and who live in a jurisdiction where it is legally available through a state-regulated program — currently Oregon and Colorado. Because psilocybin is not FDA-approved, anyone considering it should review the evidence carefully, understand the legal status in their state, and seek care only through a regulated program with appropriate medical and psychological oversight.

Neuro Wellness offers SAINT® and standard TMS, along with SPRAVATO® (esketamine), IV ketamine, psychotherapy, and medication management — all FDA-cleared or FDA-approved treatments for depression. We do not offer psilocybin therapy. A free consultation is the best way to learn which of our FDA-cleared options fits your diagnosis and circumstances.

For more comparisons, see our guides to SAINT® vs ketamine, SAINT® vs SPRAVATO®, and what treatment-resistant depression means.