Treatment-resistant depression (TRD) is when individuals diagnosed with depression do not experience significant improvement in their symptoms despite receiving adequate treatment with conventional antidepressant medications. Approximately one-third of people with depression may develop TRD.
This condition can be challenging to manage and significantly impacts the individual's quality of life. Treatment options for TRD often involve alternative approaches such as psychotherapy, augmentation strategies, or novel interventions like ketamine or esketamine. Close collaboration between patients and healthcare professionals is crucial to develop personalized treatment plans that address the unique needs of individuals with TRD.
Clinical StudyA clinical study investigated how baseline irritability affects the clinical outcomes of adults with treatment-resistant depression (TRD) treated with fixed or flexible doses of esketamine nasal spray combined with a newly initiated oral antidepressant (ESK+AD).
Additionally, the study aimed to explore whether the treatment with ESK had any impact on irritability symptoms over time. The research involved the analysis of data pooled from two phase 3 studies called TRANSFORM-1 and TRANSFORM-2. A total of 560 adults with TRD were included in the study and were randomly assigned to either the ESK+AD group or the placebo nasal spray plus oral antidepressant (AD+PBO) group.
The level of irritability was assessed using Item 6 of the 7-item Generalized Anxiety Disorder scale at screening and baseline. Changes in depression severity were evaluated using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, and treatment response and remission rates were examined.