Exploratory non-randomized clinical trial of subcutaneous esketamine in treatment-resistant depression: Effects of ketamine-assisted psychotherapy.
Yves Martins Varela, Patricia Cavalcanti-Ribeiro, Geovan Menezes de Sousa et al.
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In 30 seconds
This exploratory, non-randomized clinical trial assessed the effects of ketamine-assisted psychotherapy (KAP) in 46 patients with treatment-resistant depression (TRD) receiving subcutaneous esketamine. Results indicated that the KAP group had significantly lower Montgomery-Åsberg Depression Rating Scale (MADRS) scores at the seventh and eighth sessions, and higher remission rates (78.3% vs 34.8%) compared to the esketamine-only group, with a significant p-value of 0.007.
Key findings
- MADRS scores were significantly lower in the KAP group at the seventh and eighth sessions (p=0.015 and p=0.041).
- Response and remission rates were 52.2% and 34.8% in the KET group versus 78.3% and 78.3% in the KAP group.
- The between-group difference in remission rates was significant (p=0.007).
- BDI-II scores indicated earlier subjective improvement in the KAP group.
Why it matters
The study highlights the potential benefits of integrating psychotherapy with rapid-acting treatments like esketamine for patients with treatment-resistant depression, suggesting that structured support may enhance treatment outcomes.