Hovgesen Sanne Vendelbo, Licht Rasmus W Wentzer, Straszek Sune Puggaard Vogt, Christensen Ann-Eva, Vinberg Maj, Videbech Poul, Miskowiak Kamilla Woznica, Johnsen Simon, Munk Mette Marcus, Mai Manuel Linnart, Baethge Christopher, Kessing Lars Vedel, Nielsen Rene Ernst
Department of Psychiatry, Aalborg University Hospital, Aalborg, Denmark
Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
BMJ Open. 2025 Aug 27;15(8):e102406. doi: 10.1136/bmjopen-2025-102406.
Depression is the dominant phase in bipolar disorder, but the available treatments are scarce. Lithium is a first-line option in several guidelines despite limited evidence, whereas cariprazine has a well-documented efficacy for depressive episodes. By comparing lithium and cariprazine in terms of efficacy and tolerability, we aim to contribute to an evidence-based positioning of lithium in future guidelines.
An open label, randomised, multicentre, investigator-sponsored comparison of lithium versus cariprazine with a treatment duration of 8 weeks. Participants are aged 18-65 years and are suffering from a depressive episode as part of bipolar disorder, type 1 or 2. The primary outcome is the difference between the two groups in change from baseline to endpoint on Hamilton depression scale, 6 item version, based on the modified intention-to-treat population. Continuous variables will be analysed by using two-sided t-tests and mixed effects models. For categorical measures, χ tests and multivariable models will be applied. Secondary outcomes include AEs and measures of well-being, depressive, manic and suicidal symptoms, as well as cognitive function. The study is powered as a superiority trial, with a calculated study population of 122 participants.
Protocol has been approved by the regional ethical committee N-20220007 and European Medicines Agency. All participants provide written informed consent. The protocol was written according to Standard Protocol Items: Recommendations for Interventional Trials 2013 guidelines. Results will be disseminated in peer-reviewed international journals.
EU-CTR, 2024-517170-20-01; NCT05913947.
抑郁是双相情感障碍的主要阶段，但可用的治疗方法稀缺。尽管证据有限，锂盐仍是多项指南中的一线选择，而卡立普嗪对抑郁发作具有充分记录的疗效。通过比较锂盐和卡立普嗪在疗效和耐受性方面的差异，我们旨在为锂盐在未来指南中的循证定位做出贡献。
一项开放标签、随机、多中心、研究者发起的锂盐与卡立普嗪对比研究，治疗持续时间为8周。参与者年龄在18至65岁之间，患有1型或2型双相情感障碍的抑郁发作。主要结局是基于改良意向性治疗人群，两组在汉密尔顿抑郁量表6项版本上从基线到终点的变化差异。连续变量将使用双侧t检验和混合效应模型进行分析。对于分类指标，将应用χ检验和多变量模型。次要结局包括不良事件、幸福感、抑郁、躁狂和自杀症状以及认知功能的测量。该研究作为一项优效性试验进行设计，计算得出的研究人群为122名参与者。
方案已获得地区伦理委员会N - 20220007和欧洲药品管理局的批准。所有参与者均提供书面知情同意书。方案是根据《干预性试验标准方案项目：2013年建议》指南编写的。结果将在同行评审的国际期刊上发表。
EU - CTR，2024 - 517170 - 20 - 01；NCT05913947。
