This Phase III interventional trial (n=676) will evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants with treatment-resistant major depressive disorder (MDD) experiencing a moderate to severe depressive episode.
Conducted by Janssen-Cilag International NV, the study focuses on individuals with MDD characterised by symptoms like low mood, weight changes, sleep disturbances, and fatigue persisting for more than two weeks. Esketamine, known for its distinct mechanism of action from conventional antidepressants, is used in various doses (28 mg, 56 mg, 84 mg) alongside a continuing SSRI/SNRI treatment. The comparator arm involves quetiapine XR augmentation to the current SSRI/SNRI therapy. Spanning approximately 36 weeks, the study includes a Screening Phase, an Acute Phase of 8 weeks, a 24-week Maintenance Phase, and a 2-week Safety Follow-up Phase. Safety assessments include monitoring adverse events, physical examinations, vital signs, and electrocardiogram evaluations.
The primary outcome is remission as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) score at Week 8. Secondary outcomes include relapse rates, changes in MADRS scores, clinical global impression scores, participant-reported depressive symptoms, functional impairment, quality of life, and work productivity. The trial also prioritises safety by evaluating treatment-emergent adverse events and suicidal ideation or behaviour. This comprehensive study aims to address the unmet need for rapid and long-lasting relief of depressive symptoms in individuals with treatment-resistant depression.
Trial Details
The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.NCT Number NCT04338321
Sponsors & Collaborators
Janssen-CilagThis company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Efficacy of esketamine nasal spray over quetiapine extended release over the short and long term: sensitivity analyses of ESCAPE-TRD, a randomised phase IIIb clinical trialThis robustness analysis of the ESCAPE-TRD Phase IIIb trial (n=676) investigates esketamine nasal spray versus quetiapine extended release for treatment-resistant depression (TRD). Esketamine significantly outperformed quetiapine in achieving remission at week 8 (MADRS ≤10) and maintaining relapse-free status through week 32, with hazard ratios favouring esketamine (HR: 1.658–1.711, p < 0.001).
Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression
This open-label Phase IIIb trial (n=676) compared the efficacy of esketamine nasal spray and extended-release quetiapine, combined with an SSRI or SNRI, in patients with treatment-resistant depression (TRD). The study found that a significantly higher percentage of patients in the esketamine group achieved remission at week 8 (27.1% vs 17.6%) and had no relapse through week 32 after remission at week 8 (21.7% vs 14.1%). Adverse events were consistent with the established safety profiles of the trial treatments.