Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of... | NCT02431845

Studies
Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive Disorder

NCT02431845

Sponsor

Severance Hospital

Status

Recruiting

Last Update Posted

Dec 27, 2024Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Obsessive-Compulsive Disorder

Interventions

SSRIs

Countries

South Korea

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

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Apr 23, 2015

First Submission Date that Met QC Criteria

Apr 27, 2015

First Posted Date

May 1, 2015Estimated

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

Dec 24, 2024

Last Update Posted Date

Dec 27, 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

The purpose of this study is to determine whether pharmaco(epi)genetic study predict selective serotonin reuptake inhibitor (SSRI) responsiveness in advance before the appearance of the drug effect until 4 months(16 weeks), 6 months, and 1 year after administration of SSRIs.

Detailed Description

The purpose of this study is to determine the effects of (epi)genetic variants on the response to SSRIs in obsessive-compulsive disorder (OCD) subject.

The investigators will recruit drug-naive or drug-free(> 3 months) OCD subjects (n=200). The participants will get SSRIs for their OCD symptoms. The type and dose of SSRIs will not be restricted and will depend on the individual participant's state. However, the investigators will be recommended to follow usual clinical guideline (the Korean treatment algorithm for OCD, 2004). At baseline, 4 month, 6 months, and 1 year after treatment, the participants will be evaluated by Yale-Brown Obsessive-Compulsive Scale(YBOCS), Montgomery Asberg Depression Rating Scale(MADRS), Dimensional Obsessive-Compulsive Scale(DOCS), Toronto alexithymia scale (TAS), interpersonal reactivity index (IRI), Barratt impulsiveness scale (BIS), and the Measure of Constructs Underlying Perfectionism(M-CUP), Beck Depression Inventory(BDI), Beck Anxiety Inventory(BAI), Intolerance of Uncertainty (IOU), Metacognition, Disgust scale, Early Trauma Inventory (ETI). And a part of participants will be taken resting state functional MRI.

The research participants will donate approximately 10-15 ml of blood, from which we will extract DNA and separate serum. Using various (epi)genetic analyses, proteomics, and microbiome analysis (circulating bacterial extracellular vesicles) methods, we will analyze the association of various (epi)genetic variants, protein profiles, microbiome and the anti-obsessive-compulsive responses.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SSRIs treatment as usual OCD gruop	Experimental	SSRIs treatment as usual fluoxetine 40~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine)	Drug: SSRIs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SSRIs	Drug	usual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40~80 mg dose equivalents	SSRIs treatment as usual OCD gruop

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the Yale-Brown Obsessive-Compulsive Scale	rating scale for obsessive-compulsive symptom severity consisting of 10 items	baseline, 3 or 4 months, 6 months, 1 year

Secondary Outcomes

Measure	Description	Time Frame
Change from the baseline Montgomery-Asberg Depression Rating Scale	rating scale for depressive symptom severity consisting of 10 items, Various psychometric characteristics	baseline, 3 or 4 months, 6 months, 1 year
Occurrence of any side effects during the SSRIs treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 19~ 70
OCD by Diagnostic and Statistical Manual for Mental disorders, 4th edition (DSM-IV)
drug naive or drug free for more than 3 months

Exclusion Criteria:

any neurological disorder
comorbid psychotic disorders
alcohol or other substance dependence within past 6 months
any evidences for brain diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Se Joo Kim, M.D.	Contact	+82-2-2228-1627		kimsejoo@yuhs.ac
Jee In Kang, M.D.	Contact	+82-2-2228-1630		jeeinkang@yuhs.ac

Overall Officials

Name	Affiliation	Role
Se Joo Kim, M.D.	Professor, Department of Psychiactry, Yonsei Univ. College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei Univ. Health System Severance Hospital	Recruiting	Seoul		120-752	South Korea

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
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017367	Selective Serotonin Reuptake Inhibitors

Ancestor Terms

ID	Term
D014179	Neurotransmitter Uptake Inhibitors
D049990	Membrane Transport Modulators
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided