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NCT Number: NCT02431845

Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive Disorder

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.

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SSRIs

Drug

usual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40~80 mg dose equivalents

Other names: five kinds of SSRIs including fluoxetine

Primary outcomes

  1. Change from baseline in the Yale-Brown Obsessive-Compulsive Scale

    Time frame: baseline, 3 or 4 months, 6 months, 1 year

    rating scale for obsessive-compulsive symptom severity consisting of 10 items

Secondary outcomes

  1. Change from the baseline Montgomery-Asberg Depression Rating Scale

    Time frame: baseline, 3 or 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: 3 or 4 months, 6 months, 1 year

    any adverse events related to SSRI use

Study contacts

Contact information is provided by the study sponsor or research team.

Jee In Kang, M.D.

CONTACT

[email protected]

+82-2-2228-1630

Se Joo Kim, M.D.

CONTACT

[email protected]

+82-2-2228-1627

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive

Important dates

Study start
2013
Primary completion
2030
Study completion
2030
First posted
May 1, 2015
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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