NCT01250847Unknown4 期
Phase IV Study of Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- California Verbal Learning Test
研究概览
简要总结
The primary objective of this study is to assess the effects of 'Seroquel-XR' on the verbal learning ability in people with at-risk mental state (ARMS) over a 12 week period. The verbal learning ability will be indexed by delayed free recall score of CVLT(California Verbal learning Test), a standard neuropsychological verbal memory tests.
The secondary objective is to assess the effects of 'Seroquel-XR' on other cognitive function and psychiatric symptoms including psychotic, anhedonic symptoms, and impulsivity. The cognitive function abilities will be measured by standard neuropsychological tests as follows;
- Working memory: verbal & spatial 2-back test
- Attention: Digit Span, 3-7 CPT(Continuous Performance Test)
- Executive function: WCST (Wisconsin Card Sorting Test)
- Visuo-spatial ability: Rey Complex Figure Task copy
- Visuomotor speed and planning: Trail making test A & B
- Verbal fluency: Controlled Oral Word Association Test(COWAT) The scales of psychiatric symptoms which will be used are as follows;
- Psychotic symptoms: Scales of Prodromal scales (SOPS), Positive and negative syndrome scale (PANSS)
- Anhedonia: Social Anhedonia Scale (SAS), Physical Anhedonia Scale (PAS)
- Social cognition: Ambiguous Intention Hostility Questionnaire (AIHQ)
- Impulsivity: Barrett Impulsivity Scale (BIS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent
- •Male and female aged 20 to 35 years
- •Able to understand and comply with the requirements of the study
- •Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
- •ARMS was diagnosed by Structured Interview for Prodromal Syndrome (SIPS) .
- •Schizophrenia subjects:
- •Schizophrenia was diagnosed by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV). Patients with schizophrenia had to have been ill no more than 5 years. Subjects had to be clinically stable and on stable antipsychotic therapy for at least 4 weeks prior to baseline study.
- •Normal control:
- •Healthy volunteers who had no history of psychiatric illness and had no first degree relative with psychotic symptoms were included for normal controls.
排除标准
- •Pregnancy or lactation
- •Any DSM-IV Axis I disorder not defined in the inclusion criteria. However, in the case of ARMS, psychotic disorder NOS, major depressive disorder, obsessive-compulsive disorder, and social phobia would be allowed.
- •Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- •Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
- •Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
- •Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- •Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- •Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- •Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- •Involvement in the planning and conduct of the study
- •Previous enrolment or randomisation of treatment in the present study.
- •Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- •A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) more than 8.5 percent.
- •Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
- •Not under physician care for DM Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
- •Physician responsible for patient's DM care has not approved patient's participation in the study Has not been on the same dose of oral hypoglycaemic drug(s) and(or) diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 weeks.
- •Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10 percent above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- •An absolute neutrophil count (ANC) of 1.5 folded 109 per liter
研究组 & 干预措施
Healthy Control Comparator
No Intervention
The subjects will not be required to treat
干预措施: Quetiapine(Seroquel-XR) 50~800mg a day (Drug)
Seroquel-XR
Experimental
The subjects At-Risk Mental States will be treated with Quetiapine(Seroquel-XR) from baseline to end of trial.
干预措施: Quetiapine(Seroquel-XR) 50~800mg a day (Drug)
Schizophrenia Comparator
Experimental
The subject with schizophrenia will be treated with standard treatment
干预措施: Quetiapine(Seroquel-XR) 50~800mg a day (Drug)
结局指标
主要结局
California Verbal Learning Test
时间窗: 12th week
Change from baseline in Verbal learning ability measured by CVLT at 12 weeks
次要结局
- verbal & spatial 2-back test, Digit Span, 3-7 CPT, WCST, Rey-CFT, TMT A & B, COWAT, SOPS, PANSS, SAS, PAS, AIHQ, BIS(12th week)
研究者
研究点 (2)
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