Randomised trial of Blood pressure Rapid Intensive Lowering And Normal Treatment for Mood and Cognition in Persistent Depression (BRILiANT Mood Study)

快速强化降低血压和正常治疗持续性抑郁症情绪和认知的随机试验（BRILiANT 情绪研究）

• 批准号: MR/J011835/1
• 负责人: Alan Jeffrey Thomas
• 金额: $ 36.77万
• 依托单位: Newcastle University
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2012
• 资助国家: 英国
• 起止时间: 2012 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FJ011835%2F1
• 关键词: Randomised; trial; Blood; pressure; Rapid

Depression is a very common illness in people of all ages and many people with severe (clinically relevant) depression (called major depression) remain unwell after standard treatments with antidepressant drugs and talking therapies. The persistence of key symptoms of depression in these people makes it very difficult for them to function normally in their daily lives at work or at home and consequently contributes a lot to the high cost of looking after people with depression. Two types of persistent symptom are those related to mood (such as reduced ability to enjoy oneself) and those related to memory ('memory problems' such as forgetting things and difficulty in reasoning). There is therefore a great need to find new types of treatment. Since depression seems to be an illness with different causes and patterns of symptoms then it seems unlikely that a single new treatment will help everyone. A different approach is to find subgroups of people who seem to share the same cause of their illness. One such subgroup is people with high blood pressure (hypertension) since there is evidence that hypertension causes changes in the brain which may be an important cause of persisting symptoms in middle-aged and older people with major depression. Poorly treated hypertension is common since about a half of middle aged and older people have hypertension and half of these are not properly treated. Such hypertension changes the blood vessels which supply the brain and makes them more likely to fail to adequately supply the blood the brain needs. This is thought to cause parts of the brain not to function normally and lead to the persistent symptoms of depression and the disability this produces. Previous research shows that treating hypertension much more rapidly (over a few weeks) and with more drugs than usual can be done safely and leads not only to better control of blood pressure but to improved bloodflow in the brain. This is called rapid intensive BP lowering. The increase in bloodflow in the brain with this treatment might allow improvement of these persistent symptoms so people get completely well from their depression. However, this intensive BP lowering treatment has not been tried before in depression and so we don't know if doing this will help treat depression. We therefore propose to test this by comparing those who have normal treatment for their hypertension with people receiving the intensive BP lowering regime. We will recruit 60 people who have persistent symptoms of major depression and hypertension that needs better treatment. We will recruit people aged 50 to 80 because such hypertension is more common in this age group (about a quarter of such older adults have inadequately treated hypertension). These people will be randomly allocated to a standard hypertension treatment group (following NICE recommendations) or intensive hypertension treatment group. They will be seen regularly by a study doctor who will monitor their BP, check for any side-effects and alter their treatment depending on which treatment group they are in. Before beginning treatment and at the end of the 12 week study period different research staff, who do not know which treatment patients are receiving, will ask questions to rate patients' mood and 'memory symptoms' to compare the effects of intensive BP lowering with the standard hypertension treatment. They will also have a special brain scan to measure bloodflow in the brain before treatment and after 12 weeks and the scientist rating this again will not know which treatment they have had. We have chosen 12 weeks because studies of depression treatments usually allow 6 weeks to look for benefits and we know it takes 6 weeks to have a significant improvement in bloodflow in the brain with the rapid intensive BP lowering treatment.

抑郁症是所有年龄段人群中非常常见的疾病，许多患有严重（临床相关）抑郁症（称为重度抑郁症）的人在使用抗抑郁药物和谈话疗法进行标准治疗后仍然不适。这些人持续存在抑郁症的主要症状，使他们在工作或家庭的日常生活中很难正常发挥作用，因此导致照顾抑郁症患者的高成本。两种类型的持续性症状是与情绪有关的症状（如享受自己的能力下降）和与记忆有关的症状（“记忆问题”，如忘记事情和推理困难）。因此，迫切需要找到新的治疗方法。由于抑郁症似乎是一种具有不同原因和症状模式的疾病，因此似乎不太可能有一种新的治疗方法可以帮助每个人。一种不同的方法是找到那些似乎有着相同病因的人群。其中一个亚组是高血压患者（高血压），因为有证据表明，高血压会导致大脑的变化，这可能是中年和老年抑郁症患者持续症状的重要原因。治疗不当的高血压是常见的，因为大约一半的中年和老年人患有高血压，其中一半没有得到适当的治疗。这种高血压改变了供应大脑的血管，使它们更有可能无法充分供应大脑所需的血液。这被认为会导致大脑的某些部分不能正常工作，并导致抑郁症的持续症状和由此产生的残疾。以前的研究表明，更快地（几周内）治疗高血压，使用比平常更多的药物可以安全地进行，不仅可以更好地控制血压，还可以改善大脑的血流。这被称为快速密集的BP降低。通过这种治疗增加大脑中的血流量可能会改善这些持续性症状，使人们从抑郁中完全康复。然而，这种强化的降血压治疗在抑郁症中还没有尝试过，所以我们不知道这样做是否有助于治疗抑郁症。因此，我们建议通过比较那些接受正常治疗的高血压患者与接受强化降压治疗的患者来测试这一点。我们将招募60名患有持续性重度抑郁症和高血压症状，需要更好治疗的人。我们将招募50至80岁的人，因为这种高血压在这个年龄组中更常见（大约四分之一的老年人没有充分治疗高血压）。这些人将被随机分配到标准高血压治疗组（遵循NICE建议）或强化高血压治疗组。他们将定期接受研究医生的检查，医生将监测他们的血压，检查是否有任何副作用，并根据他们所处的治疗组改变治疗。在开始治疗之前和12周研究期结束时，不知道患者正在接受哪种治疗的不同研究人员将询问患者的情绪和“记忆症状”，以比较强化降压与标准高血压治疗的效果。他们还将接受特殊的大脑扫描，以测量治疗前和12周后大脑中的血流量，科学家再次对此进行评级将不知道他们接受了哪种治疗。我们选择了12周，因为抑郁症治疗的研究通常允许6周的时间来寻找益处，我们知道需要6周的时间才能通过快速强化降压治疗显着改善大脑中的血流。

项目成果

Lessons from a pilot and feasibility randomised trial in depression (Blood pressure Rapid Intensive Lowering And Normal Treatment for Mood and cognition in persistent depression (BRILiANT mood study)).

抑郁症的试验和可行性随机试验的经验教训（血压快速降低和正常治疗持续性抑郁症的情绪和认知（Briliant Mood研究））。

• DOI: 10.1186/s40814-015-0042-y
• 发表时间: 2015
• 期刊: Pilot and feasibility studies
• 影响因子: 1.7
• 作者: Olsen K;Howel D;Barber R;Ford GA;Gallagher P;McAllister-Williams RH;Nilsson J;O'Brien J;Parker J;Thomas A
• 通讯作者: Thomas A