Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSRIs.
- Who it may be relevant to
- Registry conditions: Obsessive-Compulsive Disorder. Basic parameters: 19 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive
Overview
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.
Interventions
- Drug SSRIs
usual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40\~80 mg dose equivalents
Primary outcome measures
- Change from baseline in the Yale-Brown Obsessive-Compulsive Scale [Time frame: baseline, 3 or 4 months, 6 months, 1 year]
Secondary outcome measures (2)
- Change from the baseline Montgomery-Asberg Depression Rating Scale [Time frame: baseline, 3 or 4 months, 6 months, 1 year]
- Occurrence of any side effects during the SSRIs treatment [Time frame: 3 or 4 months, 6 months, 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Yonsei Univ. Health System Severance Hospital — Seoul
Identifiers
NCT: NCT02431845 · 4-2010-0577 and 4-2015-0655