■精神分裂症,分裂情感障碍,双相情感障碍是一种以慢性情感模式为特征的衰弱性精神疾病,行为,和认知障碍。共同的精神病理学包括改变的情感状态的重要性,思想障碍,和行为控制。此外,这些疾病具有相同的流行病学特征,包括重要的心血管疾病,新陈代谢,传染性,和呼吸道合并症,导致预期寿命缩短长达25年。营养性酮症已成功用于治疗一系列神经系统疾病,临床前数据令人信服地显示了其在精神病动物模型中的应用潜力。来自公开临床试验的最新数据表明,精神病患者的数量急剧减少,情感,精神分裂症和双相情感障碍的代谢症状。
■研究通过改良生酮饮食(MKD)在14周内对患有双相情感障碍的稳定社区患者的营养酮症的影响,分裂情感障碍,或精神分裂症。
■一项随机安慰剂对照临床试验,对100名非住院成人参与者进行诊断为双相情感障碍,分裂情感障碍,或精神分裂症,他们能够同意并愿意改变他们的饮食。
■营养师主导和医学监督的生酮饮食与遵循澳大利亚健康饮食指南14周的饮食相比。
■主要结果包括精神病学和认知测量,报告为阳性和阴性症状量表(PANSS)的症状改善和功能变化,青年躁狂症评定量表(YMS),贝克抑郁量表(BDI),世卫组织残疾时间表,影响脆弱量表和剑桥认知电池。次要代谢结果包括体重的变化,血压,肝肾功能检查,脂质分布,和胰岛素抵抗的标志物。酮和葡萄糖水平将用于研究主要和次要结果之间的相关性。任选的毛发皮质醇分析将评估长期压力和粪便微生物组组成的变化。自主神经系统活动将通过可穿戴设备(OURA环和EMBRACE腕带)以皮肤电导的形式进行测量,血氧饱和度,连续脉搏监测,呼吸频率,运动跟踪,和睡眠质量。基于已建立的临床前研究的令人鼓舞的结果,其他神经发育障碍的临床数据,以及双相情感障碍和精神分裂症的公开试验,我们预测,生酮代谢疗法将具有良好的耐受性,并可改善精神病和代谢结局,以及改善社会和社区功能的全球指标.我们还预测,酮症的水平与代谢之间可能存在相关性,认知,干预组的精神病治疗结果。
UNASSIGNED: Schizophrenia, schizoaffective disorder, and bipolar affective disorder are debilitating psychiatric conditions characterized by a chronic pattern of emotional, behavioral, and cognitive disturbances. Shared psychopathology includes the pre-eminence of altered affective states, disorders of thoughts, and behavioral control. Additionally, those conditions share epidemiological traits, including significant cardiovascular, metabolic, infectious, and respiratory co-morbidities, resulting in reduced life expectancy of up to 25 years. Nutritional ketosis has been successfully used to treat a range of neurological disorders and preclinical data have convincingly shown potential for its use in animal models of psychotic disorders. More recent data from open clinical trials have pointed toward a dramatic reduction in psychotic, affective, and metabolic symptoms in both schizophrenia and bipolar affective disorder.
UNASSIGNED: to investigate the effects of nutritional ketosis via a modified ketogenic diet (MKD) over 14 weeks in stable community patients with bipolar disorder, schizoaffective disorder, or schizophrenia.
UNASSIGNED: A randomized placebo-controlled clinical trial of 100 non-hospitalized adult participants with a diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia who are capable of consenting and willing to change their diets.
UNASSIGNED: Dietitian-led and medically supervised ketogenic diet compared to a diet following the Australian Guide to Healthy Eating for 14 weeks.
UNASSIGNED: The primary outcomes include psychiatric and cognitive measures, reported as symptom improvement and functional changes in the Positive and Negative Symptoms Scale (PANSS), Young Mania Rating Scale (YMS), Beck Depression Inventory (BDI), WHO Disability Schedule, Affect Lability Scale and the Cambridge Cognitive Battery. The secondary metabolic outcomes include changes in body weight, blood pressure, liver and kidney function tests, lipid profiles, and markers of insulin resistance. Ketone and glucose levels will be used to study the correlation between primary and secondary outcomes. Optional hair cortisol analysis will assess long-term stress and variations in fecal microbiome composition. Autonomic nervous system activity will be measured via wearable devices (OURA ring and EMBRACE wristband) in the form of skin conductance, oximetry, continuous pulse monitoring, respiratory rate, movement tracking, and sleep quality. Based on the encouraging results from established preclinical research, clinical data from other neurodevelopment disorders, and open trials in bipolar disorder and schizophrenia, we predict that the ketogenic metabolic therapy will be well tolerated and result in improved psychiatric and metabolic outcomes as well as global measures of social and community functioning. We additionally predict that a correlation may exist between the level of ketosis achieved and the metabolic, cognitive, and psychiatric outcomes in the intervention group.