A new 2.5-year study confirms Spravato’s long-term safety and effectiveness for treatment-resistant depression, with sustained improvement and low relapse rates.
New 2.5 Year Study Confirms Spravato's Long-Term Safety and Effectiveness in Depression
Spravato has been a breakthrough treatment in mental health, providing relief to people with depression when nothing else works. A new study published in the European Neuropsychopharmacology has investigated the long-term outcomes of this treatment in real-world settings.
The Problem With Treatment-Resistant Depression
Depression is one of the most common mental health conditions in the world, but for roughly one in three people with major depressive disorder (MDD), standard antidepressants simply don't provide adequate relief.
An estimated 100 million people worldwide are classed as having treatment resistant depression (TRD). Research consistently shows that the more treatment steps a patient goes through without achieving remission, the harder remission becomes to reach, and the greater the risk of relapse once it is achieved. For this reason, research groups worldwide have sought to develop novel treatments that work differently from standard antidepressants.
Spravato is a nasal spray consisting of esketamine, one of the molecules that make up ketamine. It was developed by the pharmaceutical Johnson & Johnson after several clinical trials found esketamine could rapidly improve symptoms in patients with TRD. It was approved by the FDA for TRD in 2019 and for major depression with suicidal ideation (MDSI) one year later.
As more US citizens turn to Spravato for depression relief, Johnson & Johnson are collecting data from real-life patients with TRD to determine the drug's long-term outcomes.
About the Study: ESCAPE-LTE
The ESCAPE-LTE study is a Phase IV clinical trial that followed patients with TRD for 136 weeks, or roughly two and a half years. The study was conducted across 14 countries between April 2021 and July 2024. Results were published in February this year.
A total of 183 patients with TRD who had completed the initial ESCAPE-TRD trial on esketamine nasal spray continued into ESCAPE-LTE. All participants continued receiving esketamine nasal spray once every week or every two weeks alongside an ongoing SSRI or SNRI antidepressant.
Side Effects From Spravato Mostly Short-Lived
Over the combined 136-week treatment period, 96.7% of patients experienced at least one adverse event, such as headaches, dizziness or nausea. However, the vast majority of these events were mild to moderate in severity and 98.3% that occurred on dosing days resolved the same day.
Just over 3% of the patients discontinued the treatment because of its side effects, which is a relatively low drop out rate compared to other psychiatric medications.
Importantly, no new safety signals emerged with prolonged use. Longstanding concerns associated with ketamine, including abuse potential, renal or urinary problems, and sustained blood pressure elevations, did not materialize in a clinical context.
Spravato Has Meaningful Benefits That Continue to Improve With Time
Of the 149 patients who achieved remission during the initial ESCAPE-TRD phase, 79.2% remained in remission without relapse throughout the entire long-term extension. The overall relapse rate across both studies was just 6.9%, which is an impressive result when compared to the 33–50% relapse rates typically seen with conventional antidepressant treatments.
Patients' average depression scores continued to drop throughout the study. Psychiatrists rated the severity of their patients’ symptoms as 31.5 at baseline, according to a clinical scale, which improved to 14.7 by Week 8, and continued improving to just 6.8 by Week 136. Patient-reported scores showed a similar trajectory, falling from 17.5 at the start to 5.1 by the end of the study.
Quality of life improved substantially too, with health status scores nearly doubling from 0.4 at baseline to 0.8 by Week 32 and holding there through Week 136.
Moreover, some patients experienced remission longer into the study. Twenty-four patients who had not yet achieved remission during the initial 32-week trial went on to reach remission during the long-term extension, on average around 60 weeks into treatment. This suggests that sustained therapy can continue to yield meaningful benefits even when full results aren't immediate.
Spravato Offers Hope for Patients with Treatment-Resistant Depression
At 136 weeks of treatment, ESCAPE-LTE represents one of the longest clinical trials of any pharmacological treatment for TRD. The results are promising, given the lack of any serious side effects and continuation of improvement in symptoms.
The authors note that selecting a well-tolerated treatment like Spravato early, may prevent patients cycling through multiple different forms of therapy. This could help mitigate feelings of hopelessness, and the burden of different side effects from different treatments.
Spravato at ReYou: Long-Term Relief, Expert Care
At ReYou, our mission is to help people with TRD find a path forward when conventional treatments haven't been enough. We are leading providers of Spravato in New Jersey, delivering this treatment in a safe, supportive, and clinically supervised environment, and offering additional therapeutic support.
We understand that recovery from TRD isn't a one-size-fits-all journey and our team of experienced clinicians and therapists work with each patient individually to develop a personalized treatment plan
If you or someone you love has struggled to find relief from depression, explore what Spravato can offer by contacting the ReYou team today.
