Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia: A 6-Week Pre and Post Intervention Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Change from baseline in mean Insomnia Severity Index score
研究概览
简要总结
This will be a single center, prospective, open label, quasi-experimental pre-post intervention trial in major depressive disorder (MDD) patients with insomnia.
The main objectives are i. to assess efficacy of mirtazapine in reducing depression and insomnia symptom severity in major depressive disorder (MDD) patients with insomnia.
ii. to evaluate side effects of mirtazapine.
Following enrollment and baseline assessment patients will be prescribed mirtazapine at 15-30 mg/day. Depending on the response, doses will be adjusted after two weeks and might be titrated up to 45 mg/day.
Each patient will be monitored for 42 days and assessment will be carried out on Day 0, Day 14, Day 28 and Day 42 of the trial.
详细描述
Background: Mirtazapine is an atypical antidepressant acts by increasing noradrenergic and serotonergic neurotransmission. It inhibits presynaptic adrenergic alpha-2 receptor along with inhibition of postsynaptic serotonergic 5-HT2 and 5-HT3 receptors and histamine (H1) receptor (Jilani et al., 2022). It was approved by FDA in 1996 for treating moderate and severe depression; but it also has sedative, antiemetic, anxiolytic, and appetite stimulant effects and for these prescribed in many other psychiatric disorders (Nutt, 2002). Because of its efficacy, safety and tolerability, it is one of the drugs recommended by NICE to consider as first-choice in treating depression (Middleton et al., 2005).
A depressive episode is characterized by a period of depressed mood or diminished interest in activities occurring most of the day, nearly every day during a period lasting at least two weeks accompanied by other symptoms such as difficulty concentrating, feelings of worthlessness or excessive or inappropriate guilt, hopelessness, recurrent thoughts of death or suicide, changes in appetite or sleep, psychomotor agitation or retardation, and reduced energy or fatigue. There have never been any prior manic, hypomanic, or mixed episodes, which would indicate the presence of a bipolar disorder (ICD-11, 2019).
Around 6.7% of adult population in Bangladesh suffers from depressive disorders (NIMH, 2019). However, no interventional study has yet been carried out to see efficacy of different antidepressants in this population. As one of the frequently observed features of depression is insomnia, mirtazapine could be a good choice in these cases. This study intends to assess the efficacy of mirtazapine in major depressive disorder when the patients also present with insomnia.
General objective To assess the efficacy of mirtazapine in reducing depression with insomnia symptoms in patients with major depressive disorder (MDD) with insomnia.
Specific objectives
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
- 是
入选标准
- •Age 18-60 years.
- •Diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for MDD.
- •A ≥20 total score on the 17-item Hamilton depression rating scale (HDRS).
- •A ≥15 total score on the 7-item Insomnia Severity Index (ISI).
- •Considered to require antidepressant treatment based on the judgment of the consulting psychiatrist.
- •For women - willing to abstain from conception or willing to use modern method of contraception (she or her partner) during trial period.
排除标准
- •History of use of mirtazapine in the last 3 months period.
- •Pregnant or breastfeeding mother.
- •At significant risk for suicide.
- •Diagnosed with a primary condition including dementia as well as bipolar, obsessive-compulsive, or eating disorders, schizophrenia, or alcohol or substance dependence except for tobacco dependence.
- •Experiencing any medical conditions judged to render the patient ineligible to participate in the study.
研究组 & 干预措施
Patients with MDD with insomnia
Diagnosed MDD patients with insomnia problems will be approached and enrolled from NIMH, Dhaka.
Trial medications will be self-administered and treatment regimen will be continued until serious adverse effect develops or for 42 days, whichever occurs sooner.
Patients will receive mirtazapine at 15-30 mg/day (tablet form, once or twice daily, orally) from start. Depending on the response, doses might be increased at 2 weeks up to 45 mg/day for mirtazapine.
The clinical trial for each patient will last for 42 days. Clinical data will be collected at the beginning - Day 0 and then on Day 14 and Day 42 of the trial by face-to-face interview. A clinical follow up will be provided to trial patients on Day 28 of the trial over telephone. Research psychiatrists will also conduct follow up, medication and side effect monitoring and overall management of the patients.
干预措施: Mirtazapine Tablets (Drug)
结局指标
主要结局
Change from baseline in mean Insomnia Severity Index score
时间窗: At Day 0, Day 14 and Day 42
The Insomnia Severity Scale is a 7-item and 5-point Likert self-report questionnaire which is used to assess the nature, severity, and impact of insomnia. The total score can be between 0-35 and higher score indicates worse outcome.
Change from baseline in mean Hamilton Depression Rating Scale score
时间窗: At Day 0, Day 14 and Day 42
Hamilton Depression Rating Scale is one of the most widely used clinician-administered depression assessment scale. The 17-item version score ranges between 0-53 with higher score indicates worse outcome.
次要结局
- Change from baseline in mean World Health Organization Quality of Life score(Day 0 and Day 42)
- Frequency and severity of side effects experienced by trial patients as measured by Antidepressant Side-Effect Checklist(Day 14 and Day 42)
研究者
Dr. Ahsan Aziz Sarkar
Co-investigator
National Institute of Mental Health, Dhaka