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

NCT02431845 | Recruiting DMC

• 1 other identifier: 4-2010-0577 and 4-2015-0655
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Pharmaco(epi)genetics; Microbiome; Proteome

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Yale-Brown Obsessive-Compulsive Scale

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

  baseline, 3 or 4 months, 6 months, 1 year

Secondary Outcomes (2)

• Change from the baseline Montgomery-Asberg Depression Rating Scale

  baseline, 3 or 4 months, 6 months, 1 year

• Occurrence of any side effects during the SSRIs treatment

  3 or 4 months, 6 months, 1 year

Study Arms (1)

SSRIs treatment as usual OCD gruop

EXPERIMENTAL

SSRIs treatment as usual fluoxetine 40\~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine)

Drug: SSRIs

Interventions

SSRIs DRUG

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

Also known as: five kinds of SSRIs including fluoxetine

SSRIs treatment as usual OCD gruop

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• any neurological disorder
• comorbid psychotic disorders
• alcohol or other substance dependence within past 6 months
• any evidences for brain diseases

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (1)

Yonsei Univ. Health System Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Officials

• Se Joo Kim, M.D.

  Professor, Department of Psychiactry, Yonsei Univ. College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Se Joo Kim, M.D.

CONTACT

+82-2-2228-1627; kimsejoo@yuhs.ac

Jee In Kang, M.D.

CONTACT

+82-2-2228-1630; jeeinkang@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open naturalistic treatment

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 1, 2015
• Study Start: January 1, 2013
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)