Mood DisordersNCT04483661
Development of Systems and Precision Medicine - Take Mood Disorder as an Example.
An observational study of Mood Disorders, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Precision medicine is to achieve individual optimal health care, given the biological mechanisms, genetic variants, and environmental measurements. Take mood disorder (MD) as an example, we aim to develop systems and precision medicine in Taiwanese population. MD is a very serious and dysfunctional mental disorder. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Mood Disorders
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Nov 2019to 31 Jul 2023
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who met the criteria will be successively recruited from the National Cheng Kung University Hospital.
Who may be able to join
- Male or female patients, 20- 70 years of age
- Major depression disorder who met the DSM-V diagnostic criteria were enrolled
- Subjects take at least one kind of antidepressant.
Who cannot join
- Pregnant or breast-feeding
- Presence of any other major psychiatric illness
- History of substance and alcohol abuse or dependence
- Presence of auto-immune disorder and infectious diseases
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University (NCKU) Hospital
Tainan
Hui Hua Chang, PhD, 886-2353535 ext. 5683, huihua@mail.ncku.edu.tw
About this study
Precision medicine is to achieve individual optimal health care, given the biological mechanisms, genetic variants, and environmental measurements. Take mood disorder (MD) as an example, we aim to develop systems and precision medicine in Taiwanese population.
MD is a very serious and dysfunctional mental disorder. Since MD patients with treatment have high risk of neurocognitive impairment and metabolic disturbances, the therapeutic strategies are of clinical importance. Individual difference of treatment outcome in MD patients would result from genetic variants, environmental factors, and their interactions. Also, the treatment outcome of MD contains multiple dimensions, including improvement of disease severity, neurocognitive function, and optimized medication strategy. However, comprehensive development of approaches to investigate the multiple dimensions of treatment outcome in MD patients is limited. In this three-year proposal, we explore the interactions of genetic variants and environmental factors (represented by psychosocial stress and gut microbiota) driven approaches to develop precision medicine.
- Conditions
- Mood Disorders
- Keywords
- mood disorder, neurocognitive function, metabolic disturbances, microbiota-gut-brain axis, genetic variant, pharmacogenomics
- Medical subject headings
- Mood Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity
Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale (17-item)
Measured: six months
Secondary outcomes (4)
The influence of environmental factor in mood disorder
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota
Measured: six months
cognitive function assessed using the Finger Tapping Test (FTT)
Measured: six months
cognitive function assessed using Wisconsin Card Sorting Test (WCST)
Measured: six months
cognitive function assessed using Continuous Performance Test (CPT)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start27 Nov 2019
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483661
- Sponsor's protocol ID
- B-ER-108-058
- Status last verified
- May 2020
- First submitted
- 21 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Systems and Precision Medicine - Take Mood Disorder as an Example.
- ClinicalTrials.gov ID
- NCT04483661
- Acronym / sponsor ID
- B-ER-108-058
- Conditions
- Mood Disorders
- Keywords
- mood disorder, neurocognitive function, metabolic disturbances, microbiota-gut-brain axis, genetic variant, pharmacogenomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 23 Jul 2020 (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.
Precision medicine is to achieve individual optimal health care, given the biological mechanisms, genetic variants, and environmental measurements. Take mood disorder (MD) as an example, we aim to develop systems and precision medicine in Taiwanese population.
MD is a very serious and dysfunctional mental disorder. Since MD patients with treatment have high risk of neurocognitive impairment and metabolic disturbances, the therapeutic strategies are of clinical importance. Individual difference of treatment outcome in MD patients would result from genetic variants, environmental factors, and their interactions. Also, the treatment outcome of MD contains multiple dimensions, including improvement of disease severity, neurocognitive function, and optimized medication strategy. However, comprehensive development of approaches to investigate the multiple dimensions of treatment outcome in MD patients is limited. In this three-year proposal, we explore the interactions of genetic variants and environmental factors (represented by psychosocial stress and gut microbiota) driven approaches to develop precision medicine.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who met the criteria will be successively recruited from the National Cheng Kung University Hospital.
Key inclusion criteria (3 listed)
- Male or female patients, 20- 70 years of age
- Major depression disorder who met the DSM-V diagnostic criteria were enrolled
- Subjects take at least one kind of antidepressant.
Key exclusion criteria (4 listed)
- Pregnant or breast-feeding
- Presence of any other major psychiatric illness
- History of substance and alcohol abuse or dependence
- Presence of auto-immune disorder and 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
Depression severity
Time frame: six months
Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale (17-item)
4 secondary outcomes
The influence of environmental factor in mood disorder
Time frame: six months
cognitive function assessed using the Finger Tapping Test (FTT)
Time frame: six months
cognitive function assessed using Wisconsin Card Sorting Test (WCST)
Time frame: six months
cognitive function assessed using Continuous Performance Test (CPT)
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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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.
National Cheng Kung University (NCKU) Hospital
Tainan, Taiwan
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 Mood Disorders, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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 23 Jul 2020. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity (time frame: six months). 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 23 Jul 2020.