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临床试验/NCT04006834
NCT04006834Unknown不适用

Hypersomnia in Major Depressive Disorder

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
350
试验地点
1
主要终点
Hypersomnia

研究概览

简要总结

Background: MDD is a common mental disorder with significant morbidities and mortalities. Recent local data suggested that depressive disorders have a prevalence of over 12% in females and nearly 7 % in males in Hong Kong general adult population. Other than insomnia, patients with MDD often complained another sleep symptom - hypersomnia (defined as daytime sleepiness or excessive sleep). Interestingly, when compared to insomnia, there is much far less research on the role of hypersomnia in MDD. However, there are available data suggested that hypersomnia is associated with greater treatment-resistance, more recurrence, and increased suicidality, suggesting a need to investigate this problem in MDD patients.

Objective: To investigate the prevalence and determine characteristics of hypersomnia amongst major depressive disorder.

Design: 2-phase study design Setting: A case-control study Participants: Patients with a history of Major Depressive Disorder from out-patient clinics in New Territories East Cluster.

Main outcome measures: Daytime sleepiness measured by MSLT, actigraphy and self-reported questionnaire (ESS), sleep duration as measured by sleep diary and actigraphy.

详细描述

Background

Significance of hypersomnia in depressive illness

Sleep disturbances are observed in up to 90% of depressed patients. Both insomnia, defined clinically as difficulty initiating and/or maintain sleep, and hypersomnia, defined as excessive daytime sleepiness (EDS) and/or excessive sleep duration, are key symptoms in the diagnostic criteria of depression. A sizeable number of studies have demonstrated clear associations between insomnia and poorer depressive outcomes. These include greater depressive symptom severity, poorer treatment response and increased risk of suicidal ideations and attempts. Persistent insomnia complaints following remission of major depressive episodes (MDE) have also been found to be associated with greater risk of recurrence, poorer overall functioning and quality of life. Compared to insomnia, there is much less research on the role of hypersomnia in depressive illness.

Studies so far have suggested a prognostic significance. Hypersomnia in depressed subjects amongst a mix of mood disorders have been linked to greater treatment-resistance, depressive relapse, higher suicidal ideations and increased risk of suicide; while hypersomnia complaints amongst general populations have predicted the risk of incident depression. More recently, studies of depressed individuals amongst a mix of mood disorders had further found that the concurrence of insomnia and hypersomnia was associated with worse symptomatology compared to patients with insomnia or hypersomnia alone. These studies also found that the concurrence of insomnia and hypersomnia had greater associations with bipolar spectrum features, which builds on from previous findings suggesting that hypersomnia itself may be a clinical marker for undetected or subsequent diagnosis of bipolar II disorders in depressed patients.

Knowledge gaps in the understanding of hypersomnia in major depression

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged between 18-64 years old with a history of MDD

排除标准

  • patients with history of bipolar disorder, schizophrenic-spectrum disorder, substance abuse, alcohol dependence, dementia, patients with history of mental retardation and those unable to give consent.

结局指标

主要结局

Hypersomnia

时间窗: 1 year

Daytime Sleepiness measured by self rated Epworth Sleepiness Scale

Depression severity

时间窗: 1 year

Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder (SIGH-SAD)

次要结局

  • Fatigue(1 year)
  • Function as indicated quality of life(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Zhang Jihui

Dr.

Chinese University of Hong Kong

研究点 (1)

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