Boere Elvira, van der Wee Nic J A, van Hemert Albert M, Webb Andrew G, de Leeuw Max
Leiden University Medical Center, Department of Psychiatry, Leiden, ZA 2333, The Netherlands.
PsyQ ParnassiaGroup Mental Health Institute, Bipolar Disorder Outpatient Clinic, Rotterdam, MA 3062, The Netherlands.
Psychoradiology. 2025 Mar 7;5:kkaf003. doi: 10.1093/psyrad/kkaf003. eCollection 2025.
Lithium treatment is considered the first-line option in the pharmacological treatment of bipolar disorder. At the same time, individual responses vary greatly, which complicates achieving rapid stabilization in many subjects with bipolar disorder. The neurobiological mechanism of action of lithium remains largely unknown, hindering the development of clinically applicable predictors of individual treatment responses. The recent introduction of ultra-high-field lithium magnetic resonance imaging (MRI) has opened up a promising avenue for better linking brain measures with clinical response to lithium treatment.
This is an observational study involving 80 adults with bipolar disorder who begin lithium as part of their regular treatment. Within 4 weeks of reaching stable therapeutic serum lithium concentrations, brain lithium concentrations will be measured by employing a 3D lithium-7 chemical shift imaging (Li CSI) sequence on a 7T MR system. The primary outcome is the clinical response to lithium treatment at 1 year follow-up, assessed using a validated questionnaire. Linear regression analysis will be used to establish correlations between brain lithium concentrations-measured through mean brain, voxel-wise, parcellation, and region-of-interest approaches-and clinical lithium response.
The BLISS study protocol (NL80214.058.22) has been approved by the Medical Ethics Committee of Leiden, The Hague, and Delft in The Netherlands. Results will be submitted for publication in peer-reviewed journals and shared with the key population.Registration Online at clinicaltrials.gov (NCT06134349), 20 November 2023.
锂盐治疗被认为是双相情感障碍药物治疗的一线选择。与此同时，个体反应差异很大，这使得许多双相情感障碍患者难以快速实现病情稳定。锂盐的神经生物学作用机制在很大程度上仍不明确，这阻碍了临床适用的个体治疗反应预测指标的开发。最近引入的超高场锂磁共振成像（MRI）为更好地将脑测量与锂盐治疗的临床反应联系起来开辟了一条有前景的途径。
这是一项观察性研究，涉及80名开始将锂盐作为常规治疗一部分的双相情感障碍成年患者。在达到稳定的治疗性血清锂浓度后的4周内，将在7T磁共振系统上采用3D锂-7化学位移成像（Li CSI）序列测量脑锂浓度。主要结局是在1年随访时对锂盐治疗的临床反应，使用经过验证的问卷进行评估。将使用线性回归分析来建立通过平均脑、体素、脑区划分和感兴趣区域方法测量的脑锂浓度与锂盐临床反应之间的相关性。
BLISS研究方案（NL80214.058.22）已获得荷兰莱顿、海牙和代尔夫特医学伦理委员会的批准。研究结果将提交至同行评审期刊发表，并与关键人群分享。于2023年11月20日在clinicaltrials.gov（NCT06134349）在线注册。
