Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment‐resistant depression
Giovanni Martinotti, Bernardo Dell’osso, Giorgio Di Lorenzo, Giuseppe Maina, Alessandro Bertolino, Massimo Clerici, Sergio Barlati, Gianluca Rosso, Marco Di Nicola, Matteo Marcatili, Giacomo D’andrea, Clara Cavallotto, Stefania Chiappini, Sergio De Filippis, Giuseppe Nicolò, Pasquale De Fazio, Ileana Andriola, Raffaella Zanardi, Domenica Nucifora, Stefania Di Mauro, Roberta Bassetti, Mauro Pettorruso, Roger S McIntyre, Stefano L. Sensi, Massimo Di Giannantonio, Antonio Vita, The Real‐esk Study Group
Bipolar Disorders January 13, 2023 DOI: 10.1111/bdi.13296 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Observational cohort Peer reviewed |
|---|---|
| Sample size | 70 |
| Population | Patients with treatment-resistant bipolar depression (B-TRD) and unipolar treatment-resistant depression (TRD) |
| Intervention | Esketamine nasal spray |
| Duration | 3-month follow-up |
| Topics | Anxiety Depression Esketamine Ketamine |
| Keywords | Tolerability Bipolar disorder Depression economics Rating scale Adverse effect Antidepressant Mood |
| Citations | 72 |
| Key findings | Esketamine was effective and well-tolerated in treatment-resistant bipolar depression, with a low risk of manic switch. |
Abstract
Background: Bipolar depression accounts for most of the disease duration in type I and type II bipolar disorder (BD), with few treatment options, often poorly tolerated. Many individuals do not respond to first-line therapeutic options, resulting in treatment-resistant bipolar depression (B-TRD). Esketamine, the S-enantiomer of ketamine, has recently been approved for treatment-resistant depression (TRD), but no data are available on its use in B-TRD.
Objectives: To compare the efficacy of esketamine in two samples of unipolar and bipolar TRD, providing preliminary indications of its effectiveness in B-TRD. Secondary outcomes included the evaluation of the safety and tolerability of esketamine in B-TRD, focusing on the average risk of an affective switch.
Methods: Thirty-five B-TRD subjects treated with esketamine nasal spray were enrolled and compared with 35 TRD patients. Anamnestic data and psychometric assessments (Montgomery-Asberg Depression Rating Scale/MADRS, Hamilton-depression scale/HAM-D, Hamilton-anxiety scale/HAM-A) were collected at baseline (T0), at one month (T1), and three months (T2) follow up.
Results: A significant reduction in depressive symptoms was found at T1 and T2 compared to T0, with no significant differences in response or remission rates between subjects with B-TRD and TRD. Esketamine showed a greater anxiolytic action in subjects with B-TRD than in those with TRD. Improvement in depressive symptoms was not associated with treatment-emergent affective switch.
Conclusions: Our results supported the effectiveness and tolerability of esketamine in a real-world population of subjects with B-TRD. The low risk of manic switch in B-TRD patients confirmed the safety of this treatment.
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 depressive symptoms at one and three months with no difference in response or remission between bipolar and unipolar groups, and showed a greater anxiolytic effect in bipolar than unipolar patients.
Synthesized
Comparable studies
Other observational and cohort studies on esketamine for anxiety, most cited first.