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Trial record 64 of 165 for:    personality AND therapy AND severity | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Information provided by (Responsible Party):
Se Joo Kim, Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: SSRIs Not Applicable

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 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.


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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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: SSRIs treatment as usual OCD gruop
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
Other Name: five kinds of SSRIs including fluoxetine




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Occurrence of any side effects during the SSRIs treatment [ Time Frame: 4 months, 6 months, 1 year ]
    any adverse events related to SSRI use



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 19~ 60
  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

Information from the National Library of Medicine

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


Contacts
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Contact: Se Joo Kim, M.D. +82-2-2228-1627 kimsejoo@yuhs.ac
Contact: Jee In Kang, M.D. +82-2-2228-1630 jeeinkang@yuhs.ac

Locations
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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    kimsejoo@yuhs.ac   
Contact: Jee In Kang, M.D.    +82-2-2228-1620    kji0354@yahoo.co.kr   
Principal Investigator: Se Joo Kim, M.D.         
Sub-Investigator: Jee In Kang, M.D.         
Sponsors and Collaborators
Severance Hospital
Investigators
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Principal Investigator: Se Joo Kim, M.D. Professor, Department of Psychiactry, Yonsei Univ. College of Medicine

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Responsible Party: Se Joo Kim, Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT02431845     History of Changes
Other Study ID Numbers: 4-2010-0577
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Se Joo Kim, Severance Hospital:
Obsessive-Compulsive Disorder
Pharmaco(epi)genetics
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Personality Disorders
Disease
Obsessive-Compulsive Disorder
Pathologic Processes
Mental Disorders
Anxiety Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors