与安慰剂相比，东莨菪碱对双相情感障碍抑郁发作患者的疗效和安全性（SCOPE-BD）：一项随机双盲安慰剂对照试验的研究方案
Efficacy and safety of scopolamine compared to placebo in individuals with bipolar disorder who are experiencing a depressive episode (SCOPE-BD): study protocol for a randomised double-blind placebo-controlled trial.
作者信息
Miravalles Cerena, Kane Ruán, McMahon Eimear, McDonald Colm, Cannon Dara M, Hallahan Brian
机构信息
The Centre for Neuroimaging and Cognitive Genomics (NICOG), Clinical Neuroimaging Lab, NCBES Galway Neuroscience Centre, College of Medicine, Nursing, and Health Sciences, National University of Ireland Galway, Galway, Ireland.
Health Research Board - Clinical Research Facility Galway, National University of Ireland Galway, Galway, Ireland.
出版信息
Trials. 2022 Apr 23;23(1):339. doi: 10.1186/s13063-022-06270-4.
BACKGROUND
Current treatment options for the management of depressive episodes in bipolar disorder are often sub-optimal, with some treatments either noted to be only partially effective or to require long durations of treatment prior to a therapeutic response. Therefore, pharmaco-therapeutic options that reduce depressive symptoms in a more rapid manner might provide a viable therapeutic option for some people. Intravenous (IV) scopolamine, a pan muscarinic antagonist, has been demonstrated in a number of studies to confer a rapid antidepressant effect, albeit no study to date has exclusively evaluated its potential therapeutic effect in a cohort consisting solely of individuals with bipolar disorder.
METHODS
Individuals with bipolar disorder who are currently experiencing a depressive episode of at least moderate severity will be included in this study. Eligible participants will undergo a screening and placebo-run in visit and will be randomised at visit 3 to the treatment or placebo group. Participants will receive the three blinded infusions over the course of 2 weeks, with two subsequent follow-up visits, 1 and 3 weeks after the last infusion visit. The total duration of the study will be approximately 6 weeks. Patients will continue their regular treatment regime in addition to study medication. Objective and subjective mood questionnaires, cognitive assessments and other psychometric instruments will be administered and recorded.
DISCUSSION
To our knowledge, this is the first study to investigate the antidepressant effects of IV scopolamine in an exclusively bipolar disorder cohort. Trial findings will contribute to the evidence base regarding the cholinergic hypothesis of mood disorders and specifically might result in an additional safe therapeutic option for the management of depressive episodes in bipolar disorder.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04211961 . December 26, 2019. EudraCT Number 2017-003112-39.
背景
双相情感障碍抑郁发作的当前治疗选择往往不尽人意，一些治疗方法要么被认为仅部分有效，要么需要长时间治疗才能产生治疗反应。因此，能更快速减轻抑郁症状的药物治疗选择可能为一些人提供可行的治疗方案。静脉注射东莨菪碱是一种泛毒蕈碱拮抗剂，多项研究已证明其具有快速抗抑郁作用，尽管迄今为止尚无研究专门评估其在仅由双相情感障碍患者组成的队列中的潜在治疗效果。
方法
本研究将纳入目前正在经历至少中度严重程度抑郁发作的双相情感障碍患者。符合条件的参与者将接受筛查和安慰剂导入期访视，并在第3次访视时随机分为治疗组或安慰剂组。参与者将在2周内接受3次盲法输注，随后在最后一次输注访视后1周和3周进行两次随访。研究总时长约为6周。患者除研究用药外将继续其常规治疗方案。将发放并记录客观和主观情绪问卷、认知评估及其他心理测量工具。
讨论
据我们所知，这是第一项专门研究静脉注射东莨菪碱对双相情感障碍队列抗抑郁作用的研究。试验结果将为情绪障碍胆碱能假说的证据库做出贡献，特别是可能为双相情感障碍抑郁发作的管理带来另一种安全的治疗选择。
试验注册
ClinicalTrials.gov NCT04211961。2019年12月26日。EudraCT编号2017 - 003112 - 39。
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