Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02431845
• Other study ID #: 4-2010-0577
• Status: Recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Severance Hospital
• Contact: Se Joo Kim, M.D.
• Phone: +82-2-2228-1627
• Email: kimsejoo[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Univ. Health System Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Occurrence of any side effects during the SSRIs treatment	any adverse events related to SSRI use	4 months, 6 months, 1 year