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Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

SSRIs

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Pharmaco(epi)genetics

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yonsei Univ. Health System Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SSRIs treatment as usual OCD gruop

Arm Description

SSRIs treatment as usual fluoxetine 40~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine)

Outcomes

Primary Outcome Measures

Change from baseline in the Yale-Brown Obsessive-Compulsive Scale

rating scale for obsessive-compulsive symptom severity consisting of 10 items

Secondary Outcome Measures

Change from the baseline Montgomery-Asberg Depression Rating Scale

rating scale for depressive symptom severity consisting of 10 items, Various psychometric characteristics

Occurrence of any side effects during the SSRIs treatment

any adverse events related to SSRI use

Full Information

NCT ID

NCT02431845

First Posted

April 23, 2015

Last Updated

May 3, 2022

Sponsor

Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02431845

Brief Title

Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder

Official Title

Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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. And all the participants will donate 5 ml of whole blood and DNA will be extracted. Using various (epi)genetic analyses methods such as genotyping, exome sequencing, and so on we will analyze the association of various (epi)genetic variants and the anti-obsessive-compulsive responses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder, Pharmaco(epi)genetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open naturalistic treatment

Masking

None (Open Label)

Masking Description

Open label study

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SSRIs treatment as usual OCD gruop

Arm Type

Experimental

Arm Description

SSRIs treatment as usual fluoxetine 40~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine)

Intervention Type

Drug

Intervention Name(s)

SSRIs

Other Intervention Name(s)

five kinds of SSRIs including fluoxetine

Intervention Description

usual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40~80 mg dose equivalents

Primary Outcome Measure Information:

Title

Change from baseline in the Yale-Brown Obsessive-Compulsive Scale

Description

rating scale for obsessive-compulsive symptom severity consisting of 10 items

Time Frame

baseline, 4 months, 6 months, 1 year

Secondary Outcome Measure Information:

Title

Change from the baseline Montgomery-Asberg Depression Rating Scale

Description

rating scale for depressive symptom severity consisting of 10 items, Various psychometric characteristics

Time Frame

baseline, 4 months, 6 months, 1 year

Title

Occurrence of any side effects during the SSRIs treatment

Description

any adverse events related to SSRI use

Time Frame

4 months, 6 months, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Se Joo Kim, M.D.

Phone

+82-2-2228-1627

kimsejoo@yuhs.ac

First Name & Middle Initial & Last Name or Official Title & Degree

Jee In Kang, M.D.

Phone

+82-2-2228-1630

jeeinkang@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Se Joo Kim, M.D.

Organizational Affiliation

Professor, Department of Psychiactry, Yonsei Univ. College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei Univ. Health System Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Se Joo Kim, M.D.

Phone

+82-2-2228-1620

kimsejoo@yuhs.ac

First Name & Middle Initial & Last Name & Degree

Jee In Kang, M.D.

Phone

+82-2-2228-1620

kji0354@yahoo.co.kr

First Name & Middle Initial & Last Name & Degree

Se Joo Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Jee In Kang, M.D.

12. IPD Sharing Statement

Plan to Share IPD

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Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder

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