Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects Stabilized With Atypical Antipsychotics: A 12-week, Open-label, Uncontrolled Study
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
- 否
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
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
Fiammetta Iannuzzo
Principal investigator
University of Messina
