Pastuszak Michał, Cubała Wiesław Jerzy, Kwaśny Aleksander
Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, 80-214, Gdańsk, Poland.
Drugs Real World Outcomes. 2024 Dec;11(4):565-571. doi: 10.1007/s40801-024-00453-y. Epub 2024 Sep 13.
Residual symptoms are frequently observed in a significant number of patients with depression, indicating an unmet need for effective management strategies to achieve functional recovery.
This observational study aimed to evaluate the impact of ketamine infusions on depressive symptoms in patients with bipolar disorder who continued their baseline psychotropic and chronic somatic treatments.
Datasets of the two consecutive real-world registries (NCT04226963 for 2019-2022; NCT05565352 from 2023 onward) for the tertiary reference center for psychiatry at the Medical University of Gdańsk (Poland) for the safety and tolerability of ketamine use in mood and anxiety disorders were retrospectively analyzed. Depressive symptoms were assessed using the Inventory of Depressive Symptomatology Self-Report 30 (IDS-SR30). Residual symptoms were identified in patients who achieved a treatment response, defined as a 50% or greater reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline to the seventh infusion.
Overall, 14 out of 22 patients met the criteria for response. The most commonly persistent depressive symptoms included sad mood (85.7%), view of my future (78.6%), difficulty falling asleep, and leaden paralysis/physical energy (both 71.4%), with the most severe being difficulty falling asleep (64.3%) and sad mood (42.9%).
This observational post hoc analysis indicates that the most frequently observed residual depressive symptoms were low mood, altered view of future, sleep disturbances, and low energy levels. This study should be treated with caution as causality does not apply, however, it reports on a real-world population of subjects with treatment-resistant bipolar depression. Establishing standardized definitions for residual symptoms could enhance the quality and comparability of future research in this area.
在大量抑郁症患者中经常观察到残留症状,这表明对实现功能恢复的有效管理策略存在未满足的需求。
本观察性研究旨在评估氯胺酮输注对继续进行基线精神药物和慢性躯体治疗的双相情感障碍患者抑郁症状的影响。
回顾性分析了波兰格但斯克医科大学精神病学三级参考中心连续两个真实世界登记处(2019 - 2022年的NCT04226963;2023年起的NCT05565352)关于氯胺酮在情绪和焦虑障碍中使用的安全性和耐受性的数据集。使用抑郁症状自评量表30(IDS - SR30)评估抑郁症状。在达到治疗反应的患者中识别残留症状,治疗反应定义为蒙哥马利 - 阿斯伯格抑郁量表(MADRS)评分从基线到第七次输注时降低50%或更多。
总体而言,22名患者中有14名符合反应标准。最常见的持续性抑郁症状包括情绪低落(85.7%)、对未来的看法(78.6%)、入睡困难以及沉重性麻痹/体力(均为71.4%),其中最严重的是入睡困难(64.3%)和情绪低落(42.9%)。
这项观察性事后分析表明,最常观察到的残留抑郁症状是情绪低落、对未来看法改变、睡眠障碍和精力水平低下。然而,由于因果关系不适用,本研究应谨慎对待,不过它报告了难治性双相抑郁的真实世界人群。为残留症状建立标准化定义可以提高该领域未来研究的质量和可比性。