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

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: SSRIs

• Registration Number: NCT02431845
• Lead Sponsor: Severance Hospital

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.

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SSRIs treatment as usual OCD gruop	SSRIs	SSRIs treatment as usual fluoxetine 40\~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from the baseline Montgomery-Asberg Depression Rating Scale	baseline, 3 or 4 months, 6 months, 1 year	rating scale for depressive symptom severity consisting of 10 items, Various psychometric characteristics
Occurrence of any side effects during the SSRIs treatment	3 or 4 months, 6 months, 1 year	any adverse events related to SSRI use

Trial Locations

Locations (1)

Yonsei Univ. Health System Severance Hospital; 🇰🇷 Seoul, Korea, Republic of