What changed
The TRANSFORM, SUSTAIN, and ASPIRE studies established SPRAVATO®'s approvals. Here is what the evidence supports — and where it stops.
The studies behind the approvals SPRAVATO®'s two FDA-approved adult indications rest on a set of phase 3 trials: the TRANSFORM program for treatment-resistant depression (including studies with and without an oral antidepressant), the ASPIRE trials for depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behavior, and the SUSTAIN program, which examined longer-term use — including whether people who responded and kept taking esketamine stayed in remission longer.
What the evidence supports - In the pivotal treatment-resistant depression study (TRANSFORM-2), adults who added SPRAVATO® to an oral antidepressant had greater symptom reduction than those who added a placebo, measured 24 hours after the first dose. - In the relapse-prevention study (SUSTAIN-1), stable responders who continued SPRAVATO® with an oral antidepressant had a longer time to relapse than responders who switched to placebo. - The ASPIRE trials evaluated SPRAVATO® added to an oral antidepressant in adults with major depressive disorder and acute suicidal ideation or behavior — the second approved indication. The labeling states the limitation that effectiveness in preventing suicide has not been demonstrated.
What the evidence does not settle - Trial follow-up was measured over weeks to months; long-term comparative evidence is limited. - Group averages describe study populations, not any individual: many participants in the trials did not respond, and response rates leave room for both benefit and non-response. - Use in people under 18 is not approved, and the trials did not focus on every group a clinic may see. - The trials studied SPRAVATO® under REMS conditions in certified settings; results may not match every real-world clinic routine.
Editorial note This summary is our interpretation of published trial results, not a claim about any person's outcome. Whether SPRAVATO® is appropriate for you — and what benefit you might expect — is a question for your prescriber, based on your history and current care. You can use our directory to find treatment centers near you.
General information, not medical advice. Sources: peer-reviewed pivotal trials (TRANSFORM, SUSTAIN, ASPIRE) and the FDA prescribing information for SPRAVATO® (NDA 211243).
More reporting on treatment updates.
This report is educational and is not medical advice. Coverage, availability and eligibility can change; verify details with the named source or your care team.