辛伐他汀增强治疗新发精神病:一项研究方案

Marieke J.H. Begemann , Maya J.L. Schutte , Margot I.E. Slot , Janine Doorduin , P. Roberto Bakker , Neeltje E.M. van Haren , Iris E.C. Sommer
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引用次数: 20

摘要

有充分的证据表明,炎症过程在精神分裂症的病理生理中起作用。随机对照试验表明,一些(但不是全部)抗炎药物对症状严重程度有好处。到目前为止,这些药物的使用时间相对较短。辛伐他汀结合了良好的血管保护和减少大脑炎症状态,因此为进一步改善精神分裂症和相关疾病的治疗提供了有吸引力的潜力。方法/设计我们目前正在进行一项双盲安慰剂对照试验,包括250名被诊断为精神分裂症谱系障碍的患者(18-50岁)。首次出现精神病的时间不应超过3年。在一年的时间里,患者在常规抗精神病药物治疗的基础上,每天以1:1的比例随机分配40mg辛伐他汀或安慰剂。主要结局指标是在基线和治疗结束时,通过阳性和阴性综合征量表(PANSS)和精神分裂症简短认知评估(BACS)测量的症状严重程度和认知能力下降。次要目标是确定脑组织损失的衰减和一般功能的改善,代谢综合征的存在和严重程度以及运动障碍的程度。最后,在血液样本中评估免疫和代谢参数,以可能预测治疗反应。与安慰剂相比,我们假设辛伐他汀可以降低症状严重程度,防止或减少过度的脑组织损失和认知能力下降。我们期望辛伐他汀具有良好的耐受性,并降低代谢综合征的患病率。临床试验注册:clinicaltrails .gov NCT01999309;EudraCT-number 2013-000834-36。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Simvastatin augmentation for recent-onset psychotic disorder: A study protocol

Background

There is ample evidence that inflammatory processes play a role in the pathophysiology of schizophrenia. Randomized controlled trials have shown benefit of some (but not all) anti-inflammatory drugs on symptom severity. So far, these drugs have been given for a relatively short period. Simvastatin combines well-established vascular protection with reduction of the inflammatory status of the brain, thus offering an attractive potential to further improve treatment of schizophrenia and related disorders.

Methods/design

We are currently undertaking a double-blind placebo-controlled trial, including 250 patients (18–50 years of age) whom are diagnosed with a schizophrenia spectrum disorder. Onset of their first psychosis should be no longer than three years ago. Patients are randomized 1:1 to either 40 mg simvastatin or placebo daily during one year, next to their regular antipsychotic treatment. Primary outcome measures are symptom severity and cognitive decline as measured by the Positive and Negative Syndrome Scale (PANSS) and Brief Assessment of Cognition in Schizophrenia (BACS), at baseline and end of treatment. Secondary aims are to establish an attenuation of brain tissue loss and an improvement in general functioning, presence and severity of metabolic syndrome and degree of movement disorders. Lastly, immunological and metabolic parameters are assessed in blood samples to possibly predict treatment response.

Discussion

We hypothesize simvastatin to lower symptom severity and to prevent or reduce excessive brain tissue loss and cognitive decline, compared to placebo. We expect that simvastatin will be well-tolerated and lead to decreased prevalence of metabolic syndrome.

Trial registration

ClinicalTrails.gov NCT01999309; EudraCT-number 2013-000834-36.

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