Esketamine in treatment-resistant depression patients comorbid with substance-use disorder: A viewpoint on its safety and effectiveness in a subsample of patients from the REAL-ESK study
Stefania Chiappini, Giacomo D’andrea, Sergio De Filippis, Marco Di Nicola, Ileana Andriola, Roberta Bassetti, Sergio Barlati, Mauro Pettorruso, Stefano L. Sensi, Massimo Clerici, Bernardo Dell’osso, Antonio Vita, Giovanni Martinotti
European Neuropsychopharmacology May 4, 2023 DOI: 10.1016/j.euroneuro.2023.04.011 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Observational, retrospective, multicentre study Peer reviewed |
|---|---|
| Sample size | 26 |
| Population | Patients with treatment-resistant depression and a substance use disorder |
| Intervention | Esketamine nasal spray |
| Duration | 3-month follow-up |
| Topics | Anxiety Depression Addiction Esketamine Ketamine |
| Keywords | Tolerability Depression economics Antidepressant Comorbidity Rating scale Adverse effect Substance abuse Observational study Mood |
| Citations | 48 |
| Key findings | Esketamine nasal spray reduced depression scores and was well tolerated in patients with treatment-resistant depression comorbid with a substance use disorder, with no reported abuse or misuse. |
Abstract
Esketamine, the S-enantiomer of ketamine, has recently emerged as a therapy for treatment-resistant depression (TRD), showing both rapid antidepressant action and good efficacy and high safety. It is also indicated for the acute short-term treatment of psychiatric emergency due to major depressive disorder (MDD) and for depressive symptoms in adults with MDD with acute suicidal thoughts/behavior. We here provide preliminary insights on esketamine nasal spray (ESK-NS) effectiveness and safety among patients with a substance use disorder (SUD) within the sample of patients with TRD collected for the observational, retrospective, multicentre REAL-ESK study. Twenty-six subjects were retrospectively selected according to the presence of a SUD in comorbidity. Subjects enrolled completed the three different follow-up phases (T0/baseline, T1/after one month, and T2/after three months) and there were no dropouts. A decrease in Montgomery-Asberg depression rating scale (MADRS) scores was recorded, thus highlighting the antidepressant efficacy of ESK-NS (MADRS decreased from T0 to T1, t = 6.533, df=23, p<0.001, and from T1 to T2, t = 2.029, df=20, p = 0.056). Considering tolerability and safety issues, one or more side effects were reported by 19/26 subjects (73%) after treatment administration. All reported side effects were time-dependent and did not cause significant sequelae; among them, dissociative symptoms (38%) and sedation (26%) were the most frequently reported. Finally, no cases of abuse or misuse of ESK-NS were reported. Despite study limitations related to the inherent nature of the study, a limited number of patients, and a short follow-up period, ESK-NS showed to be effective and safe in patients diagnosed with TRD comorbid with a SUD.
In the evidence
This study is part of the evidence base for a synthesis in the library. Here is how each one recorded it.
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Esketamine reduced depression scores over three months and was well tolerated, with no reported abuse or misuse.
Synthesized
Comparable studies
Other observational and cohort studies on esketamine for anxiety, most cited first.