Spravato Now Approved as Monotherapy for Depression: A Breakthrough Available at Elevate Medical

In January 2025, the U.S. Food and Drug Administration (FDA) approved this groundbreaking treatment for adults who haven’t found relief from at least two traditional oral antidepressants.

This marks a pivotal moment in psychiatric care—and it’s available right here at Elevate Medical, your dedicated Spravato Treatment Center.

What Makes This Approval So Significant?

Until now, Spravato was used only in combination with an oral antidepressant. The latest FDA approval is a game-changer: Spravato is now approved to be used on its own (as a monotherapy), giving patients a new path forward—especially those who have cycled through multiple medications with little to no relief.

With over 140,000 patients already treated globally, Spravato’s growing reputation as a rapid-acting treatment is supported by both real-world success and rigorous clinical trials.

The TRD4005 Study: What the Science Shows

This approval was backed by the TRD4005 clinical trial, a Phase 4, double-blind, placebo-controlled study involving 477 adults with major depressive disorder who had failed to respond to at least two oral antidepressants.

Here’s what the trial revealed:

• Patients received Spravato (56 mg or 84 mg) or placebo twice weekly for four weeks.

• After just four weeks, 22.5% of patients receiving Spravato achieved clinical remission (compared to 7.6% on placebo).

• Remarkably, many patients showed improvement within 24 hours of their first dose.

The results confirm what many in the field suspected: Spravato works differently—and for many, it works faster and more effectively than conventional antidepressants.

Safety and Monitoring at Elevate Medical

Spravato’s effectiveness comes with important safety considerations, which is why it is only available through certified treatment centers like Elevate Medical.

As part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, we provide:

• A calm, medically supervised setting for every treatment session.

• Monitoring for side effects such as dizziness, dissociation, or sedation.

• Personalized treatment schedules based on your unique response and needs.

Why Choose Elevate Medical for Spravato Treatment?

At Elevate Medical, we don’t just treat symptoms—we elevate lives. Our dedicated team of mental health professionals is trained in administering Spravato safely and effectively. We understand the struggles of treatment-resistant depression, and we are committed to providing compassionate, cutting-edge care.

Whether you’re new to Spravato or exploring it as a next step in your mental health journey, our clinic is here to guide you every step of the way—from initial consultation to long-term recovery support.

Ready to Take the Next Step?

If you or a loved one is living with depression that hasn’t improved with traditional medications, Spravato may be the breakthrough you’ve been waiting for.

Contact Elevate Medical today to schedule your consultation and see if Spravato is right for you.

Conveniently located, medically advanced, and patient-centered—Elevate Medical is here to help you rise above treatment-resistant depression.

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