Clinical trial NCT02431845: Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive Disorder
Official title: Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
Pharmaco(epi)genetics
Microbiome
Proteome
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2015-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open naturalistic treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the Yale-Brown Obsessive-Compulsive Scale
timeFrame: baseline, 3 or 4 months, 6 months, 1 year
Secondary outcomes:
measure: Change from the baseline Montgomery-Asberg Depression Rating Scale
timeFrame: baseline, 3 or 4 months, 6 months, 1 year
measure: Occurrence of any side effects during the SSRIs treatment
timeFrame: 3 or 4 months, 6 months, 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Univ. Health System Severance Hospital
Study officials:
affiliation: Professor, Department of Psychiactry, Yonsei Univ. College of Medicine
name: Se Joo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: