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

Recruiting

• Conditions: Depression

• Registration Number: NCT05076643
• Lead Sponsor: Universiti Tunku Abdul Rahman

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-13
• Study Start: 2022-03-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-24
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 397

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic, TCM body constitution, psychological factors and dietary pattern are significant predictors for depression among university students.	Baseline	Univariate and multivariate logistic regression will be performed.

Secondary Outcome Measures

Name	Time	Method
Prevalence of depression among university students.	Baseline	Patient Health Questionnaire (PHQ-9): Non depressed = 0 - 9; Depressed = 10 - 27
Protein significantly expressed between depressed and non-depressed students.	Baseline	Liquid chromatography-mass spectrometry (LC-MS) will be performed.

Trial Locations

Locations (1)

Universiti Tunku Abdul Rahman; 🇲🇾 Kajang, Selangor, Malaysia