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Hypersomnia in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT04006834
Recruitment Status : Recruiting
First Posted : July 3, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Zhang Jihui, Chinese University of Hong Kong

Brief Summary:

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.


Condition or disease Intervention/treatment
Major Depressive Disorder Other: No intervention involved

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hypersomnia in Major Depressive Disorder
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MDD with hypersomnia
Patient with a history of MDD and ESS >10
Other: No intervention involved
No intervention involved

MDD without hypersomnia
Patient with a history of MDD and ESS <=10
Other: No intervention involved
No intervention involved




Primary Outcome Measures :
  1. Hypersomnia [ Time Frame: 1 year ]
    Daytime Sleepiness measured by self rated Epworth Sleepiness Scale

  2. Depression severity [ Time Frame: 1 year ]
    Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder (SIGH-SAD)


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: 1 year ]
    Self rated scale by Multidimensional Fatigue Inventory (MFI)

  2. Function as indicated quality of life [ Time Frame: 1 year ]
    Self rated by 12-Item Short FOrm Survey (SF12)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be successively recruited from August 2018 to August 2019 from the out-patient psychiatric clinics within the New Territories Eastern Cluster.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006834


Contacts
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Contact: Maxine Cheung, Dr. 852-57967576 cms044@ha.org.hk
Contact: YK Wing, Prof. 852-39197593 ykwing@cuhk.edu.hk

Locations
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Hong Kong
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Jihui Zhang, PhD         
Contact: YK Wing    852-39197593    ykwing@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Zhang JiHui, Dr CUHK

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Responsible Party: Dr. Zhang Jihui, Dr., Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04006834     History of Changes
Other Study ID Numbers: CREC2018.317
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disorders of Excessive Somnolence
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases