NCT00782405已完成3 期
Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine
Technical University of Munich1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- sleep effiency
研究概览
简要总结
The purpose of this study is to examine the effects of (a) quetiapine XR and (b) mirtazapine on sleep when given as an antidepressant (monotherapy). We hypothesize that (a) quetiapine XR has an immediate and lasting positive effect on sleep in depressed patients which does not differ from the impact of mirtazapine on sleep in this group of patients; (b) in the context of a secondary objective, we expect an antidepressant effect of quetiapine XR which is equivalent to that of mirtazapine.
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
- 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
- •Provision of written informed consent
- •A diagnosis of Major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, revised (DSM-IV-R)
- •Clinically significant sleep disturbance (PSQI total score > 5)
- •Females and males aged 18 to 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 enrolment
- •Able to understand and comply with the requirements of the study
- •Minimum score in the HAMD-21 scale: 18
排除标准
- •Pregnancy or lactation
- •Any DSM-IV-R Axis I disorder not defined in the inclusion criteria
- •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 and / or mirtazapine, 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, rifampicin, 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-R criteria
- •Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV-R 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) >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 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% 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 x 109 per liter
- •Respiratory distress index during the 1st polysomnography > 10
- •Periodic leg movement / arousal index during the 1st polysomnography > 10
研究组 & 干预措施
1
Experimental
quetiapine
干预措施: quetiapine (Drug)
2
Active Comparator
mirtazapine
干预措施: mirtazapine (Drug)
结局指标
主要结局
sleep effiency
次要结局
未报告次要终点
研究者
研究点 (1)
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Effect of quetiapine XR on sleep in patients with major depression, as compared with mirtazapineDuring the past years, growing evidence of a pronounced antidepressant effect of quetiapine has been demonstrated in several studiesin the same time, quetiapine turned out to have sleep-promoting properties. Since in major depression, initial sleep complaints are among the most prominent symptoms, quetiapine appears as a drug which possibly can act simultaneously on depressive symptomatology and sleep complaints.MedDRA version: 9.1Level: LLTClassification code 10012399Term: Depressive disorderMedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSEUCTR2008-003331-20-DETechnical University Munich, Klinikum rechts der Isar
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