NCT01189318撤回2 期
Effects of Seroquel XR (Quetiapine Fumarate Extended-Release) on Sleep Architecture in Patients With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- change from baseline Pittsburgh Quality Index total scores at 4 weeks
研究概览
简要总结
In this study, patients with major depressive disorder (MDD) who have insomnia symptom are treated with Seroquel XR in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 20 and 65
- •Diagnosis of major depressive disorder as assessed by Structured Clinical Interview for DSM-IV (SCID-IV)
- •A score of 1 or greater on any of the sleep items (items 4, 5, 6) from the Hamilton Depression Rating Scale (HDRS)
- •Provision of written informed consent
- •Healthy Control Subject Inclusion Criteria:
- •Healthy Men and Women aged between 20 and 65
- •Provision of written informed consent
排除标准
- •Presence of any major physical or neurological illness (e.g.，head trauma， epilepsy，seizure，stroke，cerebral tumor，multiple sclerosis，cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity，etc.)
- •Diagnosis of any Axis I disorder other than major depressive disorder or presence of symptoms requiring hospitalization
- •Drug abuse in past 3 months
- •Women who are pregnant，breastfeeding, or planning pregnancy
- •Contraindications to drugs used in the study (e.g., allergy, intolerance, etc.)
- •Unstable medical illness or severe abnormality in laboratory test at screening assessment
- •Increase in blood glucose, lipid, and calcium levels at screening
- •Low blood pressure at screening assessment
- •Intelligence quotient below 80
- •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 3 months prior to enrolment
- •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
- •Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •A patient with Diabetes Mellitus
- •An absolute neutrophil count (ANC) of <= 1.5 x 10^9 per liter
- •Insomnia from other causes of medical or neurological diseases
- •Involvement in the planning and conduct of the study
研究组 & 干预措施
Seroquel XR
Experimental
Patients with MDD receives Seroquel XR.
干预措施: Quetiapine Fumarate Extended Release (Drug)
结局指标
主要结局
change from baseline Pittsburgh Quality Index total scores at 4 weeks
时间窗: baseline and 4 weeks
change from baseline Pittsburgh Quality Index total scores at 2 weeks
时间窗: baseline and 2 weeks
change from baseline Pittsburgh Quality Index total scores at 4 days
时间窗: baseline and 4 days
次要结局
- change from baseline in sleep architecture measured using polysomnography at 4 weeks(baseline and at 4 weeks)
- number of participants with adverse events(4 days)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University
研究点 (1)
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