Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Sheehan Disability Scale- Change from Baseline to Final Visit
研究概览
简要总结
This study will determine the efficacy of a medication switch to Aripiprazole for the treatment of schizophrenia or schizoaffective disorder in patients with moderate to high symptoms of social anxiety. Specifically the study will test the possibility that a medication switch to Aripiprazole reduces symptoms of social anxiety in this patient population.
详细描述
Although research has shown that social anxiety is very common among patients suffering from schizophrenia or schizoaffective disorder, it is rarely diagnosed and treated in this patient population. This study will determine the efficacy of a medication switch to Aripiprazole for the treatment of schizophrenia in patients with moderate to high symptoms of social anxiety. Specifically the study will test the possibility that a medication switch to Aripiprazole reduces symptoms of social anxiety in this patient population. In addition, the study will test the possibility that Aripiprazole significantly improves social adjustment, quality of life and level of functioning in these patients. The study may also assess the ability of Aripiprazole to reduce sexual dysfunction.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patient does not meet DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder
- •Patient carries a diagnosis of dementia, degenerative CNS disorders, mental retardation, substance abuse or dependence other than nicotine dependence or alcohol abuse will be excluded from the study.
- •Patients with acute medical conditions are not eligible.
- •Patients allergic or otherwise intolerant or non-responsive to Aripiprazole
- •Patient with history of suicidal, homicidal or assaultive plans or attempts in the past 6 months.
- •Clinically significant EKG or lab abnormalities
结局指标
主要结局
Sheehan Disability Scale- Change from Baseline to Final Visit
Lehman Quality of Life Interview- Change from Baseline to Final Visit
Liebowitz Social Anxiety Scale- Change from Baseline to Final Visit
次要结局
- Clinical Global Impression scales [CGI]and [CGI-C]- change from Baseline to Final Visit.
- Ultimate game paradigm as a measure of social cohesion- Change from Baseline to Final Visit
- COSAPSQ -Change from Baseline to Final Visit
- CAGE -Change from Baseline to Final Visit
- Arizona sexual dysfunction scale- Change from Baseline to Final Visit
- HAM-D-Change from Baseline to Final Visit
- PANSS- Change from Baseline to Final Visit
- Instrumental Activities of Daily Living-Change from Baseline to Final Visit