DepressionNCT05076643
Biomarkers, TCM Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression
An observational study of Depression, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
Trial summary
This study aims to determine the predictors of depression among university students in Universiti Tunku Abdul Rahman (UTAR) Sungai Long Campus. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Depression
- How many people
- 397 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Mar 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: University students
Who may be able to join
- Malaysian citizen
- Able to read and communicate in English
Who cannot join
- Special education disability (deaf and blind)
- Physical support
- History of infectious diseases
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Tunku Abdul Rahman
Kajang, Selangor, 43000
Chai Nien Foo, foocn@utar.edu.my
About this study
Official title: Biomarkers, Traditional Chinese Medicine Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression Among University Students in UTAR, Malaysia
This study aims to determine the predictors of depression among university students in Universiti Tunku Abdul Rahman (UTAR) Sungai Long Campus.
Read the 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.
- Conditions
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| University students | University students in Universiti Tunku Abdul Rahman Sungai Long Campus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic, TCM body constitution, psychological factors and dietary pattern are significant predictors for depression among university students.
Univariate and multivariate logistic regression will be performed.
Measured: Baseline
Secondary outcomes (2)
Prevalence of depression among university students.
Patient Health Questionnaire (PHQ-9):
Non depressed = 0 - 9; Depressed = 10 - 27
Measured: Baseline
Protein significantly expressed between depressed and non-depressed students.
Liquid chromatography-mass spectrometry (LC-MS) will be performed.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start17 Mar 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 397 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Foo Chai Nien, Universiti Tunku Abdul Rahman
- Investigators
- Chai Nien Foo, Principal investigator, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076643
- Sponsor's protocol ID
- IPSR/RMC/UTARRF/2019-C2/F01
- Status last verified
- Aug 2024
- First submitted
- 30 Sep 2021
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers, Traditional Chinese Medicine Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression Among University Students in UTAR, Malaysia
- ClinicalTrials.gov ID
- NCT05076643
- Acronym / sponsor ID
- IPSR/RMC/UTARRF/2019-C2/F01
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 397 participants (estimated)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| University students | – | –University students in Universiti Tunku Abdul Rahman Sungai Long Campus |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- University students
Key inclusion criteria (2 listed)
- Malaysian citizen
- Able to read and communicate in English
Key exclusion criteria (3 listed)
- Special education disability (deaf and blind)
- Physical support
- History of infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Prevalence of depression among university students.
Time frame: Baseline
Protein significantly expressed between depressed and non-depressed students.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chai Nien Foo principal investigator
Universiti Tunku Abdul Rahman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chai Nien Foo (+60123167252, foocn@utar.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic, TCM body constitution, psychological factors and dietary pattern are significant predictors for depression among university students. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.