NCT01601002已完成4 期
Does LEPR Polymorphism Predict Variability in Weight Gain Induced by Mirtazapine in the Treatment of Late Life Depression?
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- increase in weight as measured in the clinic
研究概览
简要总结
Patients with an episode of depression in late life prescribed mirtazapine recruited from a clinical sample will be monitored for weight and receive a blood test during their usual course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect weight gain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 50 years
- •meeting criteria for a diagnosis of major depressive disorder (DSM IV code 296.2x or 296.3x) as confirmed by a score > 20 on the HAM-D 24 items scale and a structured clinical interview using the SCID by a consultant psychiatrist
排除标准
- •Treatment resistant depression (as defined by failure to respond to ≥2 adequate antidepressant trials)
- •Major depressive disorder with psychosis (296.x4)
- •Those with depression who fulfill the chronic specifier (MDE for >2 years)
- •Significant Axis II pathology
- •Previous trial with mirtazapine
- •Concurrent antipsychotic usage
- •Comorbid dementia (as confirmed by MMSE < 24)
- •Substance misuse including drug and/or alcohol dependence/abuse in the past 3 months
- •Bipolar disorder
- •Schizophrenia
- •Obsessive compulsive disorder
- •Post traumatic stress disorder
- •Eating disorder
- •Head injury
- •Recent stroke (< 3 months)
- •Recent MI (< 3 months)
- •Currently actively participating in structured/formal psychotherapy
- •Being non ambulatory
- •Those actively suicidal
- •Those incapable of informed consent
研究组 & 干预措施
Mirtazapine
Experimental
Mirtazapine in dosage of 7.5 mg to 45 mg/day
干预措施: Mirtazapine (Drug)
结局指标
主要结局
increase in weight as measured in the clinic
时间窗: Weeks 1,2,4,8 and 12 weeks
次要结局
- Proportion of population achieving clinical response as measured by rate of fall in HAM-D 24 item scores(Start to end of study (12 weeks))
- Proportion of patients achieving remission at end of study on HAM-D 24 (<11)(Start to end of study (12 weeks))
- Frequency of adverse events(Start to end of study (12 weeks))
- Percentage adhering to medication(Start to end of study (12 weeks))
研究者
Akshya Vasudev
Principal Investigator
Lawson Health Research Institute
研究点 (1)
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