An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
2015年12月14日 更新者：Dr. Roumen Milev、Queen's University
OBJECTIVES:
Primary Objective:
To assess the objective (polysomnographic) changes in sleep quality before and after introduction of olanzapine in treatment of patients with depression.
Secondary Objectives:
To assess the subjective changes in sleep quality parameters before and at different stages after introduction of olanzapine in treatment, longitudinally, and to correlate these changes with measures of illness severity and changes in cognition.
STUDY DESIGN:
Prospective, double blind, randomized polysomnographic (PSG) study of patients before and after treatment with olanzapine.
PSG recordings will be done three times throughout the study: before starting olanzapine augmentation (baseline), at day 3 to 5 (acute) and day 28 to 31 (chronic). PSG will be completed at patients' homes with a portable PSG. Psychiatric scales, subjective sleep quality scales, and cognition measurements will be completed at each visit.
研究概览
研究类型
介入性
注册 (实际的)
27
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
-
Kingston、Ontario、加拿大、K7L 4X3
- Queen's University, Providence Care-Mental Health Services
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- A diagnosis of major depressive disorder or bipolar disorder type 1, 2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Current depressive episode with a HAMD-17 of > 15
- Males or females over age18 years (yrs)
- Inpatients or outpatients
- 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
- Provision of written informed consent
Exclusion Criteria:
- Current manic, hypomanic or mixed episode, with YMRS > 12
- Current or past diagnosis of schizophrenia and dementia
- Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing
- Patient on any other antipsychotic medication
- 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 olanzapine, as judged by the investigator
- Benzodiazepines and all other sleep-aids must be discontinued prior to participation in the study if they have not been at a stable dosage for the 4 weeks previous to entry into the study
- No change to the current medication regime (excluding discontinuation of sleep aids and antipsychotic medications) is allowed 4 weeks prior to the first PSG reading
- Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization
- Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Serious, unstable or inadequately treated medical illness as judged by the investigator
- History of epilepsy or uncontrolled seizures
- Involvement in the planning and conduct of the study
- Previous enrolment in the present study
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1个
|
Olanzapine will be taken once daily at 6pm for 1 month.
Dosing will be titrated up to 5mg and then changed as clinically indicated.
|
|
安慰剂比较：2个
|
An inactive form of the treatment will be taken once daily at 6pm for 1 month.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Sleep quality as measured by overnight PSG, defined as the change in time spent in slow wave sleep.
大体时间：3 days after baseline and 1 month after baseline
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3 days after baseline and 1 month after baseline
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Sleep measures: time in bed, total sleep time, sleep period time, percentage of sleep stages (stage 1, stage 2, slow wave sleep, REM sleep) of sleep period time, sleep latency to stage 1 and 2, REM latency, number of awakenings.
大体时间：measure taken at baseline, 3 days after baseline, and 1 month after baseline
|
measure taken at baseline, 3 days after baseline, and 1 month after baseline
|
|
Respiratory events (during PSG): obstructive sleep apneas, mixed apneas, central apneas, total apneas, obstructive hypopneas, mixed hypopneas, central hypopneas, total hypopneas, and apneas + hypopneas (AHI), oxygen saturation, and heart rate.
大体时间：Baseline, 3 days and 1 month after baseline
|
Baseline, 3 days and 1 month after baseline
|
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Subjective sleep experience: visual analogue scale, sleep diary, Epworth Sleep Scale and Pittsburgh Sleep Quality Index.
大体时间：Baseline, 3 days and 1 month after baseline
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Baseline, 3 days and 1 month after baseline
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Changes in weight and blood glucose will be monitored.
大体时间：At baseline and 1 month
|
At baseline and 1 month
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Cognition: CANTAB scores
大体时间：Baseline, 3 days and 1 month after baseline
|
Baseline, 3 days and 1 month after baseline
|
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Illness severity: HDRS-17, MADRS, CGI and HamA
大体时间：Baseline, 3 days and 1 month after baseline
|
Baseline, 3 days and 1 month after baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Roumen Milev, M.D.、Queen's University, Department of Psychiatry
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年10月1日
初级完成 (实际的)
2009年5月1日
研究完成 (实际的)
2009年5月1日
研究注册日期
首次提交
2007年8月22日
首先提交符合 QC 标准的
2007年8月22日
首次发布 (估计)
2007年8月24日
研究记录更新
最后更新发布 (估计)
2015年12月16日
上次提交的符合 QC 标准的更新
2015年12月14日
最后验证
2015年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.