A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Symptoms assessed on PANSS.
研究概览
简要总结
A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the treatment of 100 treatment- naive first-episode patients with schizophrenia.
详细描述
OBJECTIVE: Investigator compared the efficiency, social function, cognitive function and side effect of olanzapine and Long-acting paliperidone palmitate injection in the treatment of first-episode drug-naive patients with schizophrenia.
METHODS:
- Clinical Trial: This is a randomized trial in treatment-naive first-episode patients with schizophrenia. The study consists of a 1-week stabilization phase, followed by 12 weeks of treatment. The total trial duration is 13 weeks.
- Assessment Procedures:
2.1. Primary Outcome Variable-psychopathology: Assessment instruments include the Positive and Negative Syndrome Scale (PANSS), the Assessment of Negative Symptoms (SANS) and the Clinical Global Impression (ICG). Patients are interviewed at screening, at week-4, at week-1, at baseline and at every two weeks, for a total of 12 ratings.
2.2. Cognitive tests: A comprehensive battery of tests encompassing the cognitive domains of executive function, attention, memory, perception, and general intellect is administered twice at baseline and at the end of 16-week treatment by a trained psychologist. Scoring follows standardized procedures. The Wisconsin Card Sorting Test (WCST) is administered as a measure of executive function. The N-back (0-3 back) test is administered as a measure of working memory. Logical Memory I and II, Verbal Paired Associates I and II, Visual Reproduction I and II and Digits Forward from the Wechsler Memory Scale-Revised (WMS-R) are administered as a tests of episodic memory. The Distractibility version of Gordon Continuous Performance Test (CPT)is administered as a test of attention. A four-subtest version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R), consisting of the Arithmetic, Similarities, Picture Completion, and Digit Symbol Substitution tests is administered to obtain an estimate of current Full- Scale Intelligence Quotient (FSIQ).
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of schizophrenia or schizophreniform disorder;
- •Duration of symptoms not longer than 60 months;
- •No prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days;
- •Between 18 and 45 years of age; and
- •Current psychotic symptoms of moderate severity.
排除标准
- •A DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform;
- •Documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic, infection;
- •Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension);
- •A clinically significant ECG abnormality in the opinion of the investigator;
- •Pregnant or breast-feeding female;
- •Use of disallowed concomitant therapy;
- •History of severe allergy or hypersensitivity.
研究组 & 干预措施
Paliperidone
Drug: Paliperidone, 75-150mg/month, once a month, 12 weeks
干预措施: Paliperidone (Drug)
Olanzapine
Drug: Olanzapine, 20mg/day, twice a day, 12 weeks
干预措施: Olanzapine (Drug)
结局指标
主要结局
Symptoms assessed on PANSS.
时间窗: 12 weeks
Clinical symptoms
次要结局
- Clinical global impression assessed on CGI.(12 weeks)
- Cognitive functioning assessed on RBANS.(12 weeks)
- Number of weight change in treatment assessed on Weight gain.(12 weeks)
- Abnormal Involuntary Movement Scale assessed Abnormal Involuntary Movement Scale assessed on AIMS.(12 weeks)
研究者
Xiang Yang Zhang
Director of Biological psychiatry center,
Beijing HuiLongGuan Hospital