Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment.

Intranasal esketamine, combined with an antidepressant, significantly reduced depressive symptoms in patients with severe treatment-resistant depression. In a retrospective study of 71 patients (70% women, 85% with work disability), Montgomery-Asberg depression rating scale scores dropped from a mean baseline of 38.27 at 28, 90, and 180 days. Side effects were common but mostly mild and temporary. Patients who also received psychotherapy had lower depression scores at 90 and 180 days than those who did not. The authors argue that pharmacological treatment for treatment-resistant depression should be integrated with psychotherapy, social support, and family interventions to optimize outcomes.

Study at a glance

Abstract

Treatment-resistant depression (TRD) is defined as the failure of at least two antidepressants in adequate doses and timing during a major depressive episode. Esketamine intranasal (ESK-IN) has been approved by the Food and Drug Administration and the European Medicines Agency for the treatment of TRD in combination with other antidepressants. To assess the effectiveness and tolerability of a sample of TRD patients who received treatment with ESK-IN as part of the compassionate use program. A retrospective, observational study was carried out on patients with a diagnosis of TRD enrolled in the early access program of ESK-IN in nine centers. Effectiveness was assessed with the Montgomery-Asberg depression rating scale (MADRS) at four time points: baseline, 28, 90, and 180 days of treatment. The sample included 71 patients (70% women) with a mean baseline MADRS score of 38.27 ± 5.9 and total or partial work disability rates of 85%. ESK-IN treatment was associated with a statistically and clinically significant reduction in the severity of depressive symptoms at all time points assessed. The presence of side effects was common but the majority were mild in severity and resolved after the observation period. Those patients who received psychotherapy in combination with ESK-IN showed a significantly lower MADRS score at 90 and 180 days than those patients who did not undergo psychotherapy. ESK-IN has proven to be effective and safe in a clinical sample of patients with severe TRD. To optimize clinical outcomes, the pharmacological treatment for TRD should always be integrated into a comprehensive therapeutic plan that encompasses strategies such as psychotherapy, social support, and family interventions.