Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Weight change
研究概览
简要总结
Schizophrenia and bipolar disorder are frequently associated with an elevated risk for obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute and long term treatment of these disorders and are considered a first option on most treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight gain, disturbed glucose and lipid regulation and an increase of cardiovascular risk and mortality as well as non- adherence to treatment. There are several hypotheses attempting to explain the complex pathways that lead to antipsychotic therapeutic effects and their accompanying adverse effects. Recently, in animals receiving SGA, melatonin prevented to a large extent the body weight increase, which indicates a possible role for biological rhythms in SGA induced body weight accumulation. Melatonin is a hormone secreted by the pineal gland that follows a circadian rhythm with an increased secretion in the middle of the night. This hormone acts importantly on the suprachiasmatic nucleus and other areas in the brain and periphery. Thus melatonin is involved in a series of biological functions such as sleep regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and more recently in the regulation of metabolic processes including insulin, leptin, and lipid regulation.
Given previous results in experimental animals, the purpose of the present study is to test the potential effect of melatonin in reducing or preventing some of the metabolic disturbances associated with SGA
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and non-pregnant, non-lactating women aged between 18 and 45 years;
- •DSM-IV-TR criteria for schizophrenia or bipolar disorder type I;
- •free of concomitant medical or neurological illness (as per review of systems and general physical examination);
- •free of DSM-IV current substance abuse or a history of substance dependence in the last six months;
- •who were initiated on continuous treatment with SGA (clozapine, olanzapine, quetiapine or risperidone) for a period no greater than the last three months prior to their inclusion to the present study.
排除标准
- •were diagnosed with hypertension, diabetes mellitus, dyslipidemia, thyroid disorders or hepatic illness;
- •had a history of hypersensitivity to melatonin;
- •exhibited high risk for suicide or high risk for aggressiveness;
- •women who were not practicing reliable forms of contraception. Patients were eliminated from the study if they suspended SGA or two consecutive doses of the study capsule at any point during the follow up period.
研究组 & 干预措施
Melatonin 5mg (extended release capsules)
Subjects received melatonin (extended release) 5mg nightly during the follow up period
干预措施: Melatonin (Drug)
Placebo
Subjects received a placebo capsule nightly during the eight week follow up period.
干预措施: Placebo (Drug)
结局指标
主要结局
Weight change
时间窗: Mean change from baseline weight at 8 weeks
次要结局
- Mean change Hamilton D scores(Mean change from baseline Hamilton D score at 8 weeks)
- Mean change in systolic blood pressure(Mean change from baseline systolic blood pressure at 8 weeks)
- Mean change diastolic blood pressure(Mean change from baseline diastolic blood pressure at 8 weeks)
- Mean change waist circumference(Mean change from baseline waist circumference at 8 weeks)
- Mean change hip circumference(Mean change from baseline hip circumference at 8 weeks)
- Mean change fat mass(Mean change from baseline fat mass at 8 weeks)
- Mean change lean mass(Mean change from baseline lean mass at 8 weeks)
- Mean change total body water(Mean change from baseline total body water at 8 weeks)
- Mean change glucose(Mean change from baseline glucose at 8 weeks)
- Mean change low density lipoprotein(Mean change from baseline low density lipoprotein at 8 weeks)
- Mean change high density lipoprotein(Mean change from baseline high density lipoprotein at 8 weeks)
- Mean change triglycerides(Mean change from baseline triglycerides at 8 weeks)
- Mean change cholesterol(Mean change from baseline cholesterol at 8 weeks)
- Mean change Young Mania rating scale(Mean change from baseline Young Mania rating scale at 8 weeks)
- Mean change Positive and Negative Symptoms scale(Mean change from baseline Positive and Negative Symptoms scale at 8 weeks)
研究者
Francisco Romo Nava
MD
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente