An interventional study of SSRIs in Obsessive-Compulsive Disorder, sponsored by Severance Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Severance Hospital · Not applicable, Interventional, and Treatment
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.
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.
626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.
This study's planned enrollment of 200 is above the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Severance Hospital is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
SSRIs treatment as usual fluoxetine 40\~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine)
Drug: SSRIs
usual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40\~80 mg dose equivalents
Also known as: five kinds of SSRIs including fluoxetine
Change from baseline in the Yale-Brown Obsessive-Compulsive Scale
rating scale for obsessive-compulsive symptom severity consisting of 10 items
Time frame: baseline, 3 or 4 months, 6 months, 1 year
Change from the baseline Montgomery-Asberg Depression Rating Scale
rating scale for depressive symptom severity consisting of 10 items, Various psychometric characteristics
Time frame: baseline, 3 or 4 months, 6 months, 1 year
Occurrence of any side effects during the SSRIs treatment
any adverse events related to SSRI use
Time frame: 3 or 4 months, 6 months, 1 year
Plan to share: No
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Studies of the drug tested here: Selective Serotonin Reuptake Inhibitors
Obsessive-Compulsive Disorder →
Severance Hospital