Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT02431845|
Recruitment Status : Recruiting
First Posted : May 1, 2015
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Drug: SSRIs||Not Applicable|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open naturalistic treatment|
|Masking:||None (Open Label)|
|Masking Description:||Open label study|
|Official Title:||Pharmaco(Epi)Genetic Study of Obsessive-Compulsive Disorder|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: SSRIs treatment as usual OCD gruop
SSRIs treatment as usual fluoxetine 40~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine)
usual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40~80 mg dose equivalents
Other Name: five kinds of SSRIs including fluoxetine
- Change from baseline in the Yale-Brown Obsessive-Compulsive Scale [ Time Frame: baseline, 4 months, 6 months, 1 year ]rating scale for obsessive-compulsive symptom severity consisting of 10 items
- Change from the baseline Montgomery-Asberg Depression Rating Scale [ Time Frame: baseline, 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 [ Time Frame: 4 months, 6 months, 1 year ]any adverse events related to SSRI use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431845
|Contact: Se Joo Kim, M.D.||+email@example.com|
|Contact: Jee In Kang, M.D.||+firstname.lastname@example.org|
|Korea, Republic of|
|Yonsei Univ. Health System Severance Hospital||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Se Joo Kim, M.D. +82-2-2228-1620 email@example.com|
|Contact: Jee In Kang, M.D. +82-2-2228-1620 firstname.lastname@example.org|
|Principal Investigator: Se Joo Kim, M.D.|
|Sub-Investigator: Jee In Kang, M.D.|
|Principal Investigator:||Se Joo Kim, M.D.||Professor, Department of Psychiactry, Yonsei Univ. College of Medicine|