From the Guidelines
Esketamine is not approved for treating bipolar depression. According to the most recent evidence from 2022, esketamine is approved for the treatment of depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior, as well as for treatment-resistant depression (TRD) in adults, but not specifically for bipolar depression 1. The medication is a nasal spray form of ketamine that works as an NMDA receptor antagonist, which differs from traditional antidepressants that typically target serotonin, norepinephrine, or dopamine systems.
Some key points to consider when evaluating the use of esketamine include:
- Esketamine has been shown to improve depressive symptoms and remission rates in patients with MDD, particularly those with TRD, when used as augmentation therapy to ongoing oral antidepressant use 1.
- However, the effectiveness of esketamine in preventing suicide or reducing suicidal ideation or behavior has not been established, and it lacks long-term efficacy and safety trials in MDD 1.
- Unlike ketamine, esketamine has risk evaluation and mitigation strategy requirements, which include requirements for pharmacy, health care setting certification, and mandatory monitoring for 2 hours after treatment 1.
- For bipolar depression, clinicians typically use mood stabilizers (like lithium, lamotrigine, or valproate), certain atypical antipsychotics (such as quetiapine, lurasidone, or cariprazine), or combinations of these medications, rather than esketamine, due to the risk of triggering manic episodes 1.
Overall, while esketamine may be beneficial for certain patients with MDD or TRD, it is not currently approved for treating bipolar depression, and alternative treatment options should be considered for patients with this condition.
From the Research
Esketamine Approval for Bipolar Depression
- Esketamine is approved for treatment-resistant depression (TRD) in adults, in conjunction with an oral antidepressant, as stated in the study 2.
- However, the specific approval for bipolar depression is not explicitly mentioned in the initial study 2.
Efficacy and Safety in Bipolar Depression
- A study published in 2023 3 found that esketamine significantly reduced depressive symptoms in patients with bipolar depression, with no significant differences in response or remission rates compared to patients with unipolar treatment-resistant depression.
- Another study from 2024 4 reported that ketamine/esketamine treatment in patients with bipolar depression resulted in a significant improvement in depressive symptoms, with a low risk of manic switch.
- These findings suggest that esketamine may be effective and safe for treating bipolar depression, although more research is needed to confirm its long-term efficacy and safety.
Comparison with Other Studies
- A review article from 2021 5 highlighted the potential of esketamine as a treatment option for TRD, including its rapid onset of action and efficacy in combination with oral antidepressants.
- An earlier review from 2019 6 discussed the pharmacology and clinical data of esketamine, positioning it as a novel treatment option for TRD, although with some limitations and uncertainties regarding its use.
- Overall, the available evidence suggests that esketamine may be a viable treatment option for bipolar depression, although its specific approval and long-term efficacy require further investigation.