Chronic Kidney Disease(CKD)CKDNCT06675396
Pharmacogenomics of Mood Disorder in Chronic Kidney Disease Patients
An observational study of Chronic Kidney Disease(CKD) and Depression, run by Wonju Severance Christian Hospital.
Trial summary
By using genetic information we could predict the prevalence of mood disorder and response to treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease(CKD), Depression
- What is being tested?
- Antidepressants
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CKD without history of mood disorder
Who may be able to join
- CKD patients aged 18 to 90 years
Who cannot join
- no CKD patients, aged below 18 or above 90 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cohort Study on the Psychiatric Outcomes and Genetic Associations in Patients With Chronic Kidney Disease
By using genetic information we could predict the prevalence of mood disorder and response to treatment.
Read the detailed description
This prospective cohort study enrols patients with chronic kidney disease and gathers genetic information. By the patient's biochemical information, including genetic information, we could predict the prevalence of mood disorder and response to the antipsychotherapy.
- Conditions
- Chronic Kidney Disease(CKD), Depression
- Being tested
- Antidepressants
- Keywords
- CKD, Mood disorder
- Medical subject headings
- Renal Insufficiency, Chronic, Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantsOther
control
| Study group | Role | What they receive |
|---|---|---|
| chronic kidney with mood disorder | Patients developed mood disorder after chronic kidney disease development Receives: Other: Antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of depression
Prevalence of depression
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Young Lee, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675396
- Sponsor's protocol ID
- CKD gene
- Other IDs
- CKD Research Institute
- Acronym
- CKD
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 5 Nov 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on the Psychiatric Outcomes and Genetic Associations in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06675396
- Acronym / sponsor ID
- CKD / CKD gene
- Conditions
- Chronic Kidney Disease(CKD), Depression
- Keywords
- CKD, Mood disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Nov 2024 (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.
By using genetic information we could predict the prevalence of mood disorder and response to treatment.
Detailed description
This prospective cohort study enrols patients with chronic kidney disease and gathers genetic information. By the patient's biochemical information, including genetic information, we could predict the prevalence of mood disorder and response to the antipsychotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic kidney with mood disorder | – | Other: AntidepressantsPatients developed mood disorder after chronic kidney disease development |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD without history of mood disorder
Key inclusion criteria (1 listed)
- CKD patients aged 18 to 90 years
Key exclusion criteria (1 listed)
- no CKD patients, aged below 18 or above 90 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antidepressantscontrol | Other | chronic kidney with mood disorder |
Primary outcome
Prevalence of depression
Time frame: 10 years
Prevalence of depression
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease(CKD) and Depression, run by Wonju Severance Christian Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Young Lee Lee Jun Young Professor (800-555-5555, junyoung07@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of depression (time frame: 10 years). 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 5 Nov 2024.