Impact of Trazodone on Non-rapid Eye Movement Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sleep structure staging
研究概览
简要总结
This study used polysomnographic technology and randomly selected 60 patients who met the diagnostic criteria for depression and non-organic insomnia as stipulated in DSM-5 into an intervention group (n=30) and a control group (n=30). The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone, while the control group was given citalopram hydrobromide combined with zolpidem. Both groups underwent PSG at baseline and 1 week after medication, and were assessed with the 17-item Hamilton Depression Rating Scale, Zung Self-Rating Depression Scale, Pittsburgh Sleep Quality Index, Arnsworth Insomnia Severity Scale, Antidepressant Side Effects Checklist, and the Drug Dependence Scale neuropsychological assessment at baseline, 1, 2, and 4 weeks after medication. The study aimed to explore the effects of single use of SMAs class antidepressants versus combination with other antidepressants on non-rapid eye movement sleep stage III in patients with depression and insomnia comorbidity, and to compare the effects of depression and insomnia in the two groups.
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
- Triple (Participant, Care Provider, 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
- •Outpatient or inpatient patients;
- •18 years old ≤ 65 years old;
- •Simultaneously meet the diagnostic criteria for depression and non organic insomnia in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in the United States;
- •17 items of Hamilton Depression Rating Scale (HAMD-17) with a total score of ≥ 17 points;
- •Pittsburgh Sleep Quality Index (PSQI) ≥ 16 points;
- •Never used related antidepressants and sedative hypnotic drugs;
- •Has a certain level of visual and auditory resolution, and no comprehension barriers;
- •Capable of independently completing scale measurements;
- •Education level above primary school;
- •Obtain written informed consent from the patient, and obtain written informed consent from the legal guardian if the patient is incapacitated during the onset of the illness.
排除标准
- •Patients with comorbidities such as schizophrenia, schizophrenia, bipolar disorder, mental retardation, pervasive developmental disorder, delirium, dementia, cognitive impairment, alcohol dependence, etc
- •Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, craniocerebral trauma, cerebral ischemia or hemorrhage;
- •Patients with narrow angle glaucoma;
- •History of epilepsy and febrile seizures;
- •Individuals with a history of drug use;
- •Positive for syphilis specific antibody and AIDS antibody;
- •According to risk assessment, there are currently serious suicide attempts or individuals who are overly agitated Pregnant or lactating women, or those planning to conceive in the near future;
- •Laboratory tests indicate the presence of liver and kidney function impairment in individuals;
- •There are other individuals who meet the relevant contraindications for antidepressants.
研究组 & 干预措施
Intervention group
The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone.
干预措施: 5-hydroxytryptamine balanced antidepressants trazodone (Drug)
Control group
The control group was given citalopram hydrobromide combined with zolpidem.
干预措施: Citalopram hydrobromide combined with zolpidem (Drug)
结局指标
主要结局
Sleep structure staging
时间窗: Baseline and 1 week after medication
Monitoring sleep structure staging through Polysomnography（PSG）: W period (awake period): Refers to the time when one has not entered a sleep state； N1 stage (non rapid eye movement stage 1): light sleep stage, accounting for about 5-10%； N2 stage (non rapid eye movement stage 2): The main part of sleep, accounting for about 50%； N3 stage (non rapid eye movement stage 3): Deep sleep stage, accounting for about 20%, is crucial for memory consolidation and recovery； R phase (rapid eye movement phase): related to dreams, accounting for about 20-25%.
次要结局
- The 17 item Hamilton Depression Scale (HAMD-17)(baseline, 1, 2, and 4 weeks after medication)
- Zong's Self rating Depression Scale (SDS)(baseline, 1, 2, and 4 weeks after medication)
- The Pittsburgh Sleep Quality Index (PSQI)(baseline, 1, 2, and 4 weeks after medication)
- The Athens Insomnia Scale (AIS)(baseline, 1, 2, and 4 weeks after medication)
- The Antidepressant Side Effect Checklist (ASEC)(baseline, 1, 2, and 4 weeks after medication)
- Drug Dependence Scale (DDS)(baseline, 1, 2, and 4 weeks after medication)
研究者
Jie Tong
Prof.
Tongji University