An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Sleep quality as measured by overnight PSG, defined as the change in time spent in slow wave sleep.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
干预措施: Olanzapine (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep quality as measured by overnight PSG, defined as the change in time spent in slow wave sleep.
时间窗: 3 days after baseline and 1 month after baseline
次要结局
- Illness severity: HDRS-17, MADRS, CGI and HamA(Baseline, 3 days 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.(Baseline, 3 days and 1 month after baseline)
- 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.(measure taken at baseline, 3 days after baseline, and 1 month after baseline)
- Subjective sleep experience: visual analogue scale, sleep diary, Epworth Sleep Scale and Pittsburgh Sleep Quality Index.(Baseline, 3 days and 1 month after baseline)
- Changes in weight and blood glucose will be monitored.(At baseline and 1 month)
- Cognition: CANTAB scores(Baseline, 3 days and 1 month after baseline)
研究者
Dr. Roumen Milev
Prinicpal Investigator
Queen's University