Circadian Rhythm Dysregulation in Offspring of Parents With Bipolar Disorder

NCT03656302 | Unknown

• 1 other identifier: 03140636
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to 1) investigate the differences and variances in circadian rhythms at several levels, including physical activity, dim light melatonin onset, diurnal patterns of cortisol, and body temperature between the offspring of patients with bipolar disorder (BD) and offspring of healthy parents by using a high-risk study design; and 2) determine whether these indicators correlate with psychopathological symptoms as measured by the psychometric measurements.

Conditions

Bipolar Disorder

Keywords

Bipolar disorder; Circadian Rhythm Disorders; High-risk offspring; Endophenotypes

Outcome Measures

Primary Outcomes (1)

• Dim light melatonin onset (DLMO, free day)

  The subjects will be instructed to arrive at our sleep laboratory 9 hours before their usual bedtime. Saliva samples will be collected into clear sterile tubes every 30 minutes for eight hours, starting six hours before and 2 hours after individual's habitual bedtime. Subjects will be asked to stay in the light-controlled study room (\<30 lux in any direction of gaze) and remain awake and sit quietly.

  9 hours

Secondary Outcomes (6)

• Actigraphy and sleep diary

  one week

• Body temperature

  one week

• Circadian rhythm pattern of salivary cortisol (free day)

  24 hours

• 24-Hour Urinary 6-sulphatoxymelatonin (aMT6s) Assessment

  24 hours

• Sleep macroarchitecture by polysomnography

  One-night (nearly 8 hours)

Study Arms (2)

Case offspring

Inclusion criteria: 1\) aged 6-21 years old; 2) having at least one biological parent with a lifetime or current diagnosis of bipolar disorder; 3) being able to read, write and understand Chinese; 4) both the offspring and her/his parent(s) agree to sign the informed consent form Exclusion criteria: 1\) having lifetime history or current diagnosis of bipolar disorder; 2) having no good ability to attend this project, such as patients with dementia and mental retardation.

Control offspring

Inclusion criteria: 1\) aged 6-21 years old; 2) having no biological parent(s) with lifetime or current diagnosis of mood disorders. 3) being able to read, write and understand Chinese; 4) both the offspring and her/his parent(s) agree to sign the informed consent form. Exclusion criteria: 1\) having lifetime history or current diagnosis of bipolar disorder. 2) having no good ability to attend this project, such as patients with dementia and mental retardation.

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with BD will be recruited from psychiatry outpatient clinics in Hong Kong and mainland China. Healthy parents will be recruited from our on-going community-based projects. In addition, the investigators will also recruit subjects through public advertisement through various media such as Facebook, poster, and emails. In view of the potential sex differences in these circadian rhythms indicators of interest, the adolescent offspring of healthy parents will be age- and sex-matched to the adolescent offspring of BD parents.

You may qualify if:

• \) aged 6-21 years old; 2) having at least one biological parent with a lifetime or current diagnosis of bipolar disorder; 3) being able to read, write and understand Chinese; 4) both the offspring and her/his parent(s) agree to sign the informed consent form

You may not qualify if:

• \) having lifetime history or current diagnosis of bipolar disorder; 2) having no good ability to attend this project, such as patients with dementia and mental retardation.
• \. Control offspring
• \) aged 6-21 years old; 2) having no biological parent(s) with lifetime or current diagnosis of mood disorders. 3) being able to read, write and understand Chinese; 4) both the offspring and her/his parent(s) agree to sign the informed consent form.
• \) having lifetime history or current diagnosis of bipolar disorder. 2) having no good ability to attend this project, such as patients with dementia and mental retardation.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Kowloon Hospital: collaborator
• The Affiliated Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital): collaborator
• Shenzhen Nanshan Center for Chronic Disease Control: collaborator
• Shenzhen Baoan Center for Chronic Disease Control: collaborator
• Shenzhen Longgang Center for Chronic Disease Control: collaborator
• Shenzhen Futian Center for Chronic Disease Control: collaborator

Study Sites (1)

Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Lei B, Feng H, Yang L, Wang J, Chen J, Song W, Jiang C, Zhang K, Wang Q, Tsang JCC, Chan NY, Liu Y, Chan JWY, Pan J, Zhang B, Li T, Merikangas KR, Zhang J, Wing YK. Circadian rhythm dysfunction and psychopathology in the offspring of parents with bipolar disorder: a high-risk study in the Chinese population. Gen Psychiatr. 2024 May 22;37(3):e101239. doi: 10.1136/gpsych-2023-101239. eCollection 2024.

  PMID: 38800632 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Nervous System Diseases

Study Officials

• Jihui Zhang, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Yun Kwok Wing, MBChB

  Chinese University of Hong Kong

  STUDY CHAIR

• Siu Ping Lam

  Shatin Hospital

  STUDY DIRECTOR

• Shirley Xin Li, PhD

  Hong Kong University

  STUDY DIRECTOR

• Roger Man Kin Ng, PhD

  Kowloon Hospital

  STUDY DIRECTOR

Central Study Contacts

Jihui Zhang, PhD

CONTACT

(852) 39197647; jihui.zhang@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: September 4, 2018
• Study Start: February 11, 2017
• Primary Completion: February 28, 2020
• Study Completion: June 28, 2020
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

HK (1)