Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder

May 3, 2022 updated by: Se Joo Kim, Severance Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Yonsei Univ. Health System Severance Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Se Joo Kim, M.D.
        • Sub-Investigator:
          • Jee In Kang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. any neurological disorder
  2. comorbid psychotic disorders
  3. alcohol or other substance dependence within past 6 months
  4. any evidences for brain diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SSRIs treatment as usual OCD gruop
SSRIs treatment as usual fluoxetine 40~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine)
Drug: SSRIs
usual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40~80 mg dose equivalents
Other Names:
  • five kinds of SSRIs including fluoxetine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Investigators

  • Principal Investigator: Se Joo Kim, M.D., Professor, Department of Psychiactry, Yonsei Univ. College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

May 1, 2015

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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