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NCT Number: NCT05076643

Biomarkers, TCM Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression

This study aims to determine the predictors of depression among university students in Universiti Tunku Abdul Rahman (UTAR) Sungai Long Campus.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universiti Tunku Abdul Rahman

Kajang, Selangor, 43000, Malaysia

Location status: Recruiting

Location contact

Chai Nien Foo

CONTACT

[email protected]

About this study

University students are a high at risk group for development of depression. Identifying the determinants of depression could help in the diagnosis and treatment of this disorder. This study will incorporate questionnaire and blood sample data collection procedures on 397 subjects. Written consent will be obtained from the subjects. Eligible subjects will be given self-administered questionnaires which include Patient health questionnaire (PHQ-9), Constitution in Chinese medicine questionnaire (CCMQ), Dysfunctional Attitude Scale (DAS), Depression Anxiety Stress Scales (DASS-21) - stress and anxiety subscales, Perceived stress scale-10 (PSS-10), Rosenberg self-esteem scale (RSES), and Food frequency questionnaire (FFQ). Once the subjects completed the questionnaires, blood samples will be collected from them by a trained phlebotomist. In addition, 10 most high at risk of depression subjects (with PHQ-9 scores 10 and above) and 10 healthy subjects (with PHQ-9 scores lower than 10) will be selected randomly for protein expression to further identify the proteins that significantly expressed among them.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Malaysian citizen
  • Able to read and communicate in English

Exclusion criteria

  • Special education disability (deaf and blind)
  • Physical support
  • History of infectious diseases

Treatment and study plan

Primary outcomes

  1. Genetic, TCM body constitution, psychological factors and dietary pattern are significant predictors for depression among university students.

    Time frame: Baseline

    Univariate and multivariate logistic regression will be performed.

Secondary outcomes

  1. Prevalence of depression among university students.

    Time frame: Baseline

    Patient Health Questionnaire (PHQ-9):

    Non depressed = 0 - 9; Depressed = 10 - 27

  2. Protein significantly expressed between depressed and non-depressed students.

    Time frame: Baseline

    Liquid chromatography-mass spectrometry (LC-MS) will be performed.

Study contacts

Contact information is provided by the study sponsor or research team.

Chai Nien Foo

CONTACT

[email protected]

+60123167252

Sponsors and collaborators

Lead sponsor

Universiti Tunku Abdul Rahman

Other

Registry information

Official study title

Biomarkers, Traditional Chinese Medicine Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression Among University Students in UTAR, Malaysia

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2021
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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