NCT01593774已完成2 期
Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.
Guilan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline in weight at week eight
研究概览
简要总结
The purpose of this study is to determine whether melatonin can prevent metabolic side effects of olanzapine such as weight gain, elevated glucose concentrations and lipid abnormalities.
详细描述
Atypical antipsychotics including olanzapine are associated with significant metabolic side effects. Animal studies have suggested that melatonin might prevent some of the olanzapine-associated side effects. Melatonin is safe and is widely used as a sleep-promoting complement, and is not associated with side effects seen with other used drugs such as metformin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 year
- •First episode schizophrenia (DSM-IV-TR)
- •Ability to take medicine orally
- •Eligible for starting olanzapine
排除标准
- •Married women who are at reproductive age
- •History of taking olanzapine in the recent 3 months
- •History of allergy or intolerance to olanzapine
- •History of significant head trauma ( causing loss of consciousness more than 5 minutes or neurological or cognitive sequels)
- •Liver, kidney, cerebrovascular or cardiovascular disease
- •Diabetes, metabolic syndrome
- •Using antiepileptic (other than benzodiazepines for sleep) , antihypertensive, anticoagulant, anti-platelet drugs
- •Using inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g. omeprazole. rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil)
- •Need for administration of other antipsychotics
- •Substance abuse
研究组 & 干预措施
Melatonin
Experimental
Tablet melatonin 3 mg/day at 9 pm as intervention group for eight week
干预措施: Melatonin (Drug)
Placebo
Placebo Comparator
Placebo (with the same shape and taste as melatonin) at 9 pm as control group
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in weight at week eight
时间窗: Baseline and week eight
次要结局
- Change from baseline in Triglyceride at week 4(Baseline and week 4)
- Change from baseline in HDL at week 4(Baseline and week 4)
- Change from baseline in LDL at week 4(Baseline and week 4)
- Change from baseline in Total Cholesterol at week 4(Baseline and Week 4)
- Change from baseline in weight at week 4(Baseline and week 4)
- Change from baseline in Fasting blood sugar at week 4(Baseline and week 4)
- Change from baseline in blood pressure at week 4(Baseline and week 4)
- Change from baseline in body mass index (BMI) at week 4(Baseline and week 4)
- Change from baseline in waist to hip ratio at week 4(Baseline and week 4)
- Change from baseline in Positive and negative syndrome scale (PANSS) at week 4(Baseline and week 4)
- Change from baseline in Positive and negative syndrome scale (PANSS) at week 8(Baseline and week 8)
- Change from baseline in Triglyceride at week 48(Baseline and week 8)
- Change from baseline in HDL at week 8(Baseline and week 8)
- Change from baseline in LDL at week 8(Baseline and week 8)
- Change from baseline in Total Cholesterol at week 8(Baseline and Week 8)
- Change from baseline in Fasting blood sugar at week 8(Baseline and week 8)
- Change from baseline in blood pressure at week 8(Baseline and week 8)
- Change from baseline in body mass index (BMI) at week 8(Baseline and week 8)
- Change from baseline in waist to hip ratio at week 8(Baseline and week 8)
- Change from baseline in Insulin at week 8(Baseline and week 8)
- Number of adverse events at the end of the study in each group(Baseline, week 4, and 8)
- Changes from baseline in HOMA-IR values at week 8(Baseline and week 8)
研究者
Mohammad Jafar Modabbernia
Associate Professor of Psychiatry
Guilan University of Medical Sciences
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Melatonin and the Metabolic SyndromeMetabolic SyndromeNCT01038921Emory University39
尚未招募
不适用
The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis PatientsPeritoneal DialysisNCT06096558National Nutrition and Food Technology Institute46
尚未招募
2 期
Combine effect of tab melatonin and pectointercostal fascial block on postoperative pain management in patients undergoing open heart surgeries.CTRI/2024/05/067707AIIMS Raipur
已完成
3 期
valuation the effect of melatonin in prevention of vancomycin induced nephrotoxicityIRCT20150221021159N4Esfahan University of Medical Sciences40
招募中
3 期
effect of melatonin on prevention of delirium in admitted patientsIRCT2017061234482N1Vice chancellor for research, Kermanshah University of Medical Sciences92