背景:目前治疗双相情感障碍抑郁发作的治疗方案往往不理想,其中一些治疗要么被认为仅部分有效,要么在治疗反应之前需要长时间的治疗。因此,以更快的方式减少抑郁症状的药物治疗方案可能为某些人提供可行的治疗选择.静脉注射(IV)东pol碱,泛毒蕈碱拮抗剂,已在许多研究中证明具有快速的抗抑郁作用,尽管迄今为止还没有一项研究在仅由双相情感障碍患者组成的队列中专门评估其潜在的治疗效果.
方法:这项研究将包括目前正在经历至少中度抑郁发作的双相情感障碍患者。符合条件的参与者将在访问中进行筛选和安慰剂运行,并将在访问3时随机分配给治疗或安慰剂组。参与者将在2周内接受三次盲注,随后进行了两次后续访问,最后一次输液访问后1和3周。研究的总持续时间约为6周。除研究药物外,患者将继续其常规治疗方案。客观和主观情绪问卷,认知评估和其他心理测量工具将被管理和记录。
结论:据我们所知,本研究是首次在单纯双相情感障碍队列中研究静脉注射东莨菪碱的抗抑郁作用.试验结果将有助于有关情绪障碍的胆碱能假说的证据基础,特别是可能导致另一种安全的治疗方案,用于治疗双相情感障碍的抑郁发作。
背景:ClinicalTrials.govNCT04211961。2019年12月26日。EudraCT编号2017-003112-39。
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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT04211961 . December 26, 2019. EudraCT Number 2017-003112-39.