SUMMARY:

Janssen’s ICEBERG study has demonstrated that Esketamine nasal spray (NS) has shown improved outcomes in an indirect treatment comparison with other real-world treatments for treatment-resistant depression (TRD).

The ICEBERG study indirectly compared SUSTAIN-2, a Phase III study evaluating the efficacy of Esketamine nasal spray in combination with an SSRI as a treatment for TRD, with data from the European Observational TRD Cohort study of current-real world treatment strategies (RWTs). The European Observational TRD cohort (EOTC) was a prospective, non-interventional, multicentre study in patients starting a new, routine treatment for TRD in a real-world clinical practice.

ICEBERG discovered that Esketamine NS had significant benefits in terms of response and remission compared with other RWTs for RD. At six months, 50% of patients receiving Esketamine NS responded to treatment, compared to 26% of patients on RWTs.

The relative risk of response to treatment with Esketamine NS versus RWTs was 1.94, and the relative risk of remission following treatment with Esketamine NS versus RWTs was 1.93. These results suggest that those treated with Esketamine NS were almost twice as likely to both respond to treatment and enter remission than patients receiving RWTs.

Back in 2019, Esketamine was commercialised as Spravato, described as a “breakthrough” medication used to treat depression. It is a ‘fast-acting’ medicine, and a single puff in each nostril showed an improvement in a patient’s mental health within 24 hours. However, the ICEBERG study is the first time Esketamine has demonstrated efficacy in treating TRD in particular.

A third of people living with depression do not respond to existing treatments, and are considered to have TRD, which can have a major impact on a sufferer’s quality of life. The innovation of new treatments and therapies therefore offer a promising future for patients.

What Is Depression?

Depression (major depressive disorder) is a common and serious medical illness that negatively affects how you feel, the way you think and how you act. Fortunately, it is also treatable. Depression causes feelings of sadness and/or a loss of interest in activities you once enjoyed. It can lead to a variety of emotional and physical problems and can decrease your ability to function at work and at home.

Depression symptoms can vary from mild to severe and can include:

• Feeling sad or having a depressed mood
• Loss of interest or pleasure in activities once enjoyed
• Changes in appetite — weight loss or gain unrelated to dieting
• Trouble sleeping or sleeping too much
• Loss of energy or increased fatigue
• Increase in purposeless physical activity (e.g., inability to sit still, pacing, handwringing) or slowed movements or speech (these actions must be severe enough to be observable by others)
• Feeling worthless or guilty
• Difficulty thinking, concentrating or making decisions
• Thoughts of death or suicide

What is treatment-resistant depression definition?

Treatment-resistant depression (TRD) typically refers to inadequate response to at least one antidepressant trial of adequate doses and duration. TRD is a relatively common occurrence in clinical practice, with up to 50% to 60% of the patients not achieving adequate response following antidepressant treatment.

 

Clinicaltrialsdata: https://clinicaltrials.gov/ct2/show/NCT04599855

SOURCE: AUTHENTIC

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