The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,640
- 主要终点
- changes in psychopathology symptoms on PANSS during antipsychiatric treatment
研究概览
简要总结
A randomized, double-blind trial of the treatment effect of dose-low antipsychotics combined with low-dose sertraline in 1640 schizophrenia patients
详细描述
OBJECTIVE
This study aimed to evaluate the treatment effect of combination low-dose antipsychotics with low-dose sertraline in 1640 schizophrenia patients
METHODS:
- atypical antipsychotics and dose: including four atypical antipsychotics to form eight treatment groups: 1) olanzapine (7.5-10mg/day) combined with sertraline (50-100mg/day) group 2) only olanzapine (12.5-20mg/day) group 3) risperidone (2-3.5mg/day) combined with sertraline (50-100mg/day) group 4) only risperidone (4-6mg/day) group 5) paliperidone (3-4.5mg/day) combined with sertraline (50-100mg/day) group 6) only paliperidone (6-9mg/day) group 7) ziprasidone (60-100mg/day) combined with sertraline (50-100mg/day) group 8) only ziprasidone (120-160mg/day) group
- blood biochemical examination: including blood routine examination, liver function, renal function, thyroid function, glucose and lipid level, prolactin, and related hormones and proteins
- electrophysiological examination: including electrocardiograph, electroencephalography (EEG), and brain evoked potential
- scale assessment: each patient was assessed by four clinical psychiatrists using the following scales: 1) psychopathology: positive and negative symptoms scale (PANSS) and clinical global impression scale (CGI-S) 2) emotional symptoms: Hamilton depression rating scale (HAMD) and Hamilton anxiety rating scale (HAMA) 3) social function: personal and social performance scale (PSP) 4) side-effect: treatment emergent side-effect scale (TESS) and rating sale for extrapyramidal side-effect (RESES)
- blood drug concentration assay: including the drug concentration of olanzapine, risperidone, paliperidone, ziprasidone and sertraline, respectively
- Weigh gain measurement: to measure height, weight for each patient
The above measurement data were collected at baseline, week4, week8, week 12 and week24.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia by two senior psychiatrists
- •Between 18 and 60 years and Han Chinese
排除标准
- •A Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Axis I diagnosis other than schizophrenia
- •Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
- •Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
研究组 & 干预措施
olanzapine-sertraline combination
the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)
干预措施: olanzapine-sertraline combination (Drug)
only olanzapine
the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)
干预措施: only olanzapine (Drug)
risperidone-sertraline combination
the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)
干预措施: risperidone-sertraline combination (Drug)
only risperidone
the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)
干预措施: only risperidone (Drug)
paliperidone-sertraline combination
the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)
干预措施: paliperidone-sertraline combination (Drug)
only paliperidone
the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)
干预措施: only paliperidone (Drug)
ziprasidone-sertraline combination
the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)
干预措施: ziprasidone-sertraline combination (Drug)
only ziprasidone
the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)
干预措施: only ziprasidone (Drug)
结局指标
主要结局
changes in psychopathology symptoms on PANSS during antipsychiatric treatment
时间窗: baseline, week 4, week 8, week 12, and week 24
The Positive and Negative Syndrome Scale (PANSS) is a well-characterized and widely applied dimensional assessment that reflects a balanced representation of positive and negative syndromes, their differential and general severity of illness. The scales not only measures positive and negative syndromes, but also suggests their differential and general severity of the illness. The items on the PANSS are defined with increasing levels from 1 to 7: 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate-severe, 6 = severe, and 7 = extreme. Then the PANSS score is totaled by sum up the ratings across different items, the potential range for positive and negative scales are from 7 to 49 whereas the General Psychopathology Scale is ranged between 16 to 112.
changes in depressive symptoms on HAMD during antipsychiatric treatment
时间窗: baseline, week 4, week 8, week 12, and week 24
HAMD stands for Hamilton Rating Scale. It is the assessment that designed for examining the treatment significant of depression severity. The general format contains 17 items, 12 of them are scored from 0 to 4 while the rest of them ranges from 0 to 2. The items represented a variety of aspects: Depression mood, Feeling of guilt, Suicide, Insomnia early, Insomnia middle, Insomnia late, Work and activities, Motor retardation, Agitation, Psychic anxiety, Somatic anxiety, Somatic symptoms(gastrointestinal), somatic symptoms(general), Genital symptoms (sexual interest). Hypochondriasis, Weight loss and Insight. So A cut-off score less than or equal to 7 in the HAMD scale defines the symptomatic remission.
次要结局
- changes in electroencephalography examination for brain activity during antipsychiatric treatment(baseline, week 4, week 8, week 12, and week 24)
研究者
Xiang Yang Zhang
Professor
Beijing HuiLongGuan Hospital