A Randomized Controlled Trial to Evaluate Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Mitochondrial respiratory chain complex I activity/concentration
研究概览
简要总结
Schizophrenia is a serious mental disorder with a global prevalence of 1%. The main cause of this condition is dysfunction in the signaling of neurotransmitters dopamine, serotonin, glutamate and Gamma-aminobutyric acid .According to recent research, a disturbed cellular energy state caused by mitochondrial dysfunction is thought to be a factor in the development of schizophrenia.
The aim of the treatment of schizophrenia is to reduce symptoms and is mainly based on the monoamine hypothesis. Atypical antipsychotics are the first-line of treatment.
Certain typical and atypical antipsychotic medications have been shown in prior preclinical research to decrease mitochondrial respiratory chain complex I activity. In contrast to individuals who were drug-naive, Casademont et al. found a significant decrease in complex I activity with haloperidol and risperidone in one cross-sectional observational study. Also, there is evidence suggesting that mitochondrial dysfunction is linked to the extrapyramidal side effects seen with antipsychotics.
To date, there are no randomized controlled trials that assess the effect of these drugs on mitochondrial functions. Hence, the present randomized controlled trial has been planned to evaluate and compare the clinical and biochemical markers of mitochondrial dysfunction in schizophrenia patients treated with the atypical antipsychotics risperidone and aripiprazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients meeting the DSM-5 criteria for diagnosis of schizophrenia.
- •Treatment naıv̈ e patients or patients who had not taken any antipsychotic drugs for at least 4 weeks before recruitment.
- •Patients of either sex between the ages of 18 and 60 years.
- •Legally authorized representative (LAR) of patients consenting to participate in the study by signing the informed consent form.
排除标准
- •Patients diagnosed with other psychiatric disorders including schizoaffective disorder or schizophrenia with somatoform disorders.
- •Highly agitated patients who need immediate indoor-based treatment.
- •Patients with known mitochondrial disorders (MELAS, LHON, Leigh syndrome, KearnsSayre syndrome, MERRF etc.)
- •Patients with history of comorbidities like cardiovascular, renal, hepatic, neurological, respiratory or endocrinal diseases or malignancies.
- •Patients with history of substance abuse.
- •Pregnant or lactating mothers.
研究组 & 干预措施
Aripiprazole group
Aripiprazole will be started at dose of 10 mg/day and increased to a stable dose of 20 mg/day over 2-3 weeks and will be continued till 12 weeks.
干预措施: Aripiprazole (Drug)
Risperidone group
Risperidone will be started at dose of 2 mg/day and increased to a stable dose of 6 mg/day over 2-3 weeks and continued till 12 weeks.
干预措施: Risperidone (Drug)
结局指标
主要结局
Change in Mitochondrial respiratory chain complex I activity/concentration
时间窗: 12 weeks
Mitochondrial respiratory chain complex I activity/concentration will be measured in platelets using a commercially available ELISA (enzyme-linked immunosorbent assay) kit at baseline and at 12 weeks of follow-up.
次要结局
- Change in Serum lactate(12 weeks)
- Change in Serum creatine kinase(12 weeks)
- Change in Newcastle Mitochondrial Disease Adult Scale (NMDAS) scores(12 weeks)
- Change in Positive and Negative Syndrome Scale (PANSS) scores(12 weeks)
- Responder rate(12 weeks)
- Change in Serum pyruvate(12 weeks)
- Incidence of treatment-emergent adverse events(12 weeks)
- Severity of extrapyramidal adverse effects(12 weeks)
研究者
RITUPARNA MAITI
Professor
All India Institute of Medical Sciences, Bhubaneswar