Pharmacogenomics of Mood Disorder in Chronic Kidney Disea... | NCT06675396

Studies
Pharmacogenomics of Mood Disorder in Chronic Kidney Disease Patients

NCT06675396

Sponsor

Wonju Severance Christian Hospital

Status

Not yet recruiting

Last Update Posted

Nov 5, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Chronic Kidney Disease(CKD)
Depression

Interventions

Antidepressants

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CKD Research Institute	Other Identifier	Wonju Severance Christian hospital

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2024Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Nov 4, 2024

First Submission Date that Met QC Criteria

Nov 4, 2024

First Posted Date

Nov 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2024

Last Update Posted Date

Nov 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chronic kidney with mood disorder		Patients developed mood disorder after chronic kidney disease development	Other: Antidepressants

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antidepressants	Other	control	chronic kidney with mood disorder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of depression	Prevalence of depression	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CKD patients aged 18 to 90 years

Exclusion Criteria:

no CKD patients, aged below 18 or above 90 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with CKD without history of mood disorder

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Young Lee Lee Jun Young Professor	Contact	800-555-5555		junyoung07@yonsei.ac.kr

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D003863	Depression
D019964	Mood Disorders

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000928	Antidepressive Agents

Ancestor Terms

ID	Term
D011619	Psychotropic Drugs
D002491	Central Nervous System Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided