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临床试验/NCT06787781
NCT06787781已完成不适用

Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects Stabilized With Atypical Antipsychotics: A 12-week, Open-label, Uncontrolled Study

University of Messina1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年6月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework

研究概览

简要总结

The therapeutic use of ALA in schizophrenia has recently been investigated in human populations. A case series explored the effiacy of ALA as a novel agent to treat antipsychotic-induced obesity, at a dose of 1200 mg/d (range between 600 and 1800 mg/d); reporting the key effect to be a reduction in body weight and BMI after a 12-week treatment. In a pilot open-label trial, 100 mg/d of ALA was administrated as a general adjuvant to antipsychotics therapy, with no significant improvement in BMI, abdominal circumference, blood count, or liver enzymes. Finally, another study investigated the effects of 500 mg/d of ALA on plasma adiponectin levels, fasting glucose, and aspartate aminotransferase activity, with no significant effect on the metabolic parameters. Based on this background, ALA may be a potentially interesting therapeutic agent to improve the metabolic effects of atypical antipsychotics. The purpose of this study was to assess: (1) the efficacy of ALA on metabolic factors and (2) its safety and potential therapeutic effects in a sample of schizophrenic patients in stable therapy with atypical antipsychotics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-5 criteria for schizophrenia,
  • aged between 18 and 60 years old
  • in stable atypical antipsychotic monotherapy (clozapine, olanzapine, quetiapine, or risperidone) for least 3 months.

排除标准

  • treatment with more than one atypical antipsychotic, current treatment with insulin/oral hypoglycaemic/lipid-lowering agents
  • significant concomitant medical pathologies
  • organic brain disorders
  • history of alcohol or substance dependence (excluding nicotine)
  • mental retardation
  • pregnancy/breastfeeding.

研究组 & 干预措施

Alpha Lipoid Acid

Experimental

Subject with schizophrenia administrated with ALA

干预措施: Alpha Lipoic Acid (Drug)

结局指标

主要结局

Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework

时间窗: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

Assessment of metabolic parameters: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), trigycerides, glucose

次要结局

  • Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS)(Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fiammetta Iannuzzo

Principal investigator

University of Messina

研究点 (1)

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