NCT00441636Unknown不适用
Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of the study is to determine the effect on mood and anxiety symptoms of adding CPAP to the psychiatric treatment of patients with TRD (treatment resistant depression) and associated OSA (obstructive sleep apnea).
详细描述
Primary objective:
What is the effect on mood and anxiety symptoms of adding CPAP to the psychiatric treatment of patients with TRD and associated OSA?
Secondary objectives:
- How common is co-morbid OSA in patients with treatment resistant unipolar depression referred to a tertiary Mood Disorders Clinic?
- Is there a difference in daytime functioning (severity of depressive and anxiety symptoms, cognitive function, daytime sleepiness) and sleep quality between patients with TRD diagnosed with OSA compared with patients with TRD who have no OSA?
- What is the association between sleep fragmentation and hypoxemia and the severity of depression in patients with TRD?
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
- Single (Outcomes Assessor)
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
- 是
入选标准
- •Patients with TRD.
- •Males and females between the ages of 18 and 65 years who agree to take part and sign the Informed Consent will be invited to participate in the study.
- •Patients with co-morbid Dysthymic Disorder, Generalized Anxiety Disorder or Social Anxiety Disorder may be included in the study.
排除标准
- •Patients with uncontrolled medical illnesses will not be permitted to participate.
- •Patients with a history of current or Bipolar Disorder, Schizophrenia, Panic Disorder, Obsessive-Compulsive Disorder or Anorexia Nervosa.
- •Head injury patients resulting in loss of consciousness for more than 10 minutes.
- •Patients with epilepsy or severe personality disorders who, at the judgment of the investigators, are not appropriate candidates for the study, will be excluded.
- •Patients who do not have the mental or physical capacity to apply the CPAP interface and to plug in and switch on an auto CPAP unit at home will be excluded.
- •Blind and/or deaf patients will be excluded.
- •Patients who initially decline an offer of CPAP treatment for OSA, and those who prefer conservative treatment options (weight loss, avoidance of alcohol and sedatives) will be excluded.
- •Patients with severe claustrophobia, who cannot tolerate any CPAP interface, will be excluded.
研究组 & 干预措施
CPAP treatment
Experimental
Continuous Positive Airway Pressure (CPAP)for 4 weeks
干预措施: continuous positive airway pressure (CPAP) (Device)
No CPAP
No Intervention
routine psychiatric care for 4 weeks followed by CPAP titration and initiation after followup measures.
Control group
No Intervention
No obstructive sleep apnea detected.
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: baseline and 6 weeks
次要结局
- Epworth Sleepiness Score (ESS)(baseline and 6 weeks)
- Beck Anxiety Inventory (BAI)(baseline and 6 weeks)
- Stroop Test(baseline and 6 weeks)
- Symbol digit modalities(baseline and 6 weeks)
- Profile of mood state (POMS)(baseline and 6 weeks)
- HAM-D21(baseline and 6 weeks)
- Trail-Making test(baseline and 6 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(baseline and 6 weeks)
- SF-36 questionnaire(baseline and 6 weeks)
研究者
Dr. Ruzica Jokic
Principal Investigator
Queen's University
研究点 (2)
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