JPRN-UMIN000008743已完成未知
Augmentation therapy with aripiprazole in selective serotonin reuptake inhibitor(SSRI)-refractory obsessive-compulsive disorder(OCD); A randomized double blind placebo controlled trial - ROCAAS (Randomized controlled trial for OCD of Aripiprazole Augmentation to SSRI) Study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15years-old 至 60years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Patient who hopes for the pregnancy in childbearing woman within 4 weeks after during the study. 2)Pregnant woman, patient nursing, patient who may be pregnant 3)Patient with delirium, dementia, amnestic disorder,other cognitive impairment,mental disorder due to general physical disease, schizophrenia,bipolar disorder, substance-related disorder, agoraphobia, social phobia, panic disorder, specific phobia, PTSD, generalized anxiety disorder, somatoform disorder and eating disorder in I axis diagnosis of DSM-IV-TR. 4)patient with a part of personality disorder and mental retardation in II axis diagnosis of DSM-IV-TR. 5)participated in a clinical trial of other drugs or the medical devices for the past less than 1 month 6)Patient with score of the suicide item of the HAM-D 17 more than 3 points or patient whom PI/sub-investigator judged if at great risk of suicide for a study period from a current mental symptom and a past medical history 7)a history or a complication of diabetes,or judged to be a diabetes type blood sugar level or HbA1C(NGSP)>=6.5%,or FBS level >=126mg/dl,or casual BG level >=200mg/dl 8)history of the paroxysmal disease(epilepsy) 9)history of the obstacle of the intracranial tissue 10)Patient with the history of the paroxysmal disorder 11)Patients who meet the following criteria *T-Bil:>=3.0mg/dl *AST,ALT:over 2.5 times of NUL *CRE: >=2mg/dl *drug treatment with heart failure,arrhythmia or ischemic heart disease,etc *RBC:<3x10e6/mm3 *Hb:<10.0g/dl *WBC:<3,000/mm3 *Plt:<75,000/mm3 12) contraindication of aripiprazole a)comatose b)Strongly affected by centrally-acting suppressants such as barbiturates or anesthetics c)received adrenaline d)hipersensitivity to aripiprazole 13) Patients who have been judged by the investigator to be inappropriate for inclusion in the trial for any other reasons 14) structured systematic behavior therapy mainly on the revelation reaction interference method
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