Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: SSRIs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open naturalistic treatment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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, 4 months, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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, 4 months, 6 months, 1 year | 
| Occurrence of any side effects during the SSRIs treatment | any adverse events related to SSRI use | 4 months, 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive-Compulsive Disorder, Pharmaco(epi)genetics