NCT00912535已完成4 期
Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Comorbid Anxiety Symptoms
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Scale(HAMA-A) total score
研究概览
简要总结
The objectives of this study are to evaluate the efficacy and safety of quetiapine extended release tablet versus placebo as adjunct to selective serotonin reuptake inhibitors/serotonin/norepinephrine reuptake inhibitors (SSRI/SNRI) in the augmentation treatment of patient with primary anxiety disorders or mood disorders with co-morbid anxiety symptoms.
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
- Double (Participant, Investigator)
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
- •Provision of written informed consent
- •A diagnosis of primary anxiety disorder or mood disorder with co-morbid anxiety symptoms by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)
- •A 14-item Hamilton Anxiety Scale (HAM-A)>= 14
- •Subject have received single antidepressant at a therapeutic dose for at least 6 weeks
- •Male or female aged 18-65 years
- •Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
- •Able to understand and comply with the requirements of the study and sign informed consent
排除标准
- •Pregnancy or lactation
- •Any DSM-IV Axis I disorder not defined in the inclusion criteria.
- •Receiving any anti-psychotic 7 days prior to entering the study
- •Patients who, in the opinion of the investigator, post 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 enrollment 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 enrollment 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 randomization
- •Substance or alcohol dependence at enrollment (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 enrollment
- •Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •Unstable or inadequately treated medical illness (e.g. congestive heart failures, angina pectoris, hypertension) as judged by the investigator
- •Involvement in the planning and conduct of the study
- •Previous enrollment or randomization of treatment in the present study
- •Participation in another drug trial within 4 weeks prior enrollment 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 enrollment glycosylated hemoglobin(HbA1c)> 8.5%
- •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 randomization. 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% above or below their mean dose in the preceding 4 weeks
- •An absolute neutrophil count (ANC) of <= 1.5x10(9) per liter
研究组 & 干预措施
Quetiapine extended release tablet
Active Comparator
Quetiapine orally at a flexible dose fo 50-300mg/day according to the judgment by the investigator for 8 weeks, as adjunct to the same antidepressant at the same dose.
干预措施: Quetiapine extended release tablet (Drug)
Placebo
Placebo Comparator
Placebo orally, as adjunct to the same antidepressant at the same dose.
干预措施: Placebo (Drug)
结局指标
主要结局
Hamilton Anxiety Scale(HAMA-A) total score
时间窗: 2 months
From baseline to Week 1, Week 4 and Week 8
次要结局
- Item scores for Abnormal Involuntary Movement Scale(AIMS)(2 months)
- Item scores of Simpson-Angus Scale(SAS)(2 months)
- Item scores of Barnes-Akathisia Rating Scale (BARS)(2 months)
- Body Weight(2 months)
- Vital signs(2 months)
- Adverse event/Serious adverse event(8-9 weeks)
研究者
Chih-Ken Chen
Attending Physician
Chang Gung Memorial Hospital
研究点 (1)
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