Obsessive-Compulsive DisorderNCT02431845
Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive Disorder
A study testing SSRIs in people with Obsessive-Compulsive Disorder, run by Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- SSRIs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2013to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any neurological disorder
- comorbid psychotic disorders
- alcohol or other substance dependence within past 6 months
- any evidences for brain diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Univ. Health System Severance Hospital
Seoul, 120-752
Se Joo Kim, M.D., +82-2-2228-1620, kimsejoo@yuhs.ac
Jee In Kang, M.D., +82-2-2228-1620, kji0354@yahoo.co.kr
About this study
Official title: Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive
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.
Read the 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 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- SSRIs
- Keywords
- Obsessive-Compulsive Disorder, Pharmaco(epi)genetics, Microbiome, Proteome
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRIsDrug
Also called five kinds of SSRIs including fluoxetine
usual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40~80 mg dose equivalents
| Study group | Role | What they receive |
|---|---|---|
| SSRIs treatment as usual OCD gruop | Experimental | SSRIs treatment as usual fluoxetine 40~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine) Receives: Drug: SSRIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Yale-Brown Obsessive-Compulsive Scale
rating scale for obsessive-compulsive symptom severity consisting of 10 items
Measured: baseline, 3 or 4 months, 6 months, 1 year
Secondary outcomes (2)
Change from the baseline Montgomery-Asberg Depression Rating Scale
rating scale for depressive symptom severity consisting of 10 items, Various psychometric characteristics
Measured: 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
Measured: 3 or 4 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study start1 Jan 2013
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open naturalistic treatment
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se Joo Kim, Severance Hospital
- Investigators
- Se Joo Kim, M.D., Principal investigator, Professor, Department of Psychiactry, Yonsei Univ. College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431845
- Sponsor's protocol ID
- 4-2010-0577 and 4-2015-0655
- Status last verified
- Dec 2024
- First submitted
- 23 Apr 2015
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive
- ClinicalTrials.gov ID
- NCT02431845
- Acronym / sponsor ID
- 4-2010-0577 and 4-2015-0655
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Pharmaco(epi)genetics, Microbiome, Proteome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open naturalistic treatment
| Arm | Type | Receives |
|---|---|---|
| SSRIs treatment as usual OCD gruop | Experimental | Drug: SSRIsSSRIs treatment as usual fluoxetine 40~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- any neurological disorder
- comorbid psychotic disorders
- alcohol or other substance dependence within past 6 months
- any evidences for brain diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSRIsAlso: five kinds of SSRIs including fluoxetineusual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40~80 mg dose equivalents | Drug | SSRIs treatment as usual OCD gruop |
Primary outcome
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
2 secondary outcomes
Change from the baseline Montgomery-Asberg Depression Rating Scale
Time frame: baseline, 3 or 4 months, 6 months, 1 year
Occurrence of any side effects during the SSRIs treatment
Time frame: 3 or 4 months, 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Se Joo Kim, M.D. principal investigator
Professor, Department of Psychiactry, Yonsei Univ. College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSRIs in people with Obsessive-Compulsive Disorder, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Se Joo Kim, M.D. (+82-2-2228-1627, kimsejoo@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Yale-Brown Obsessive-Compulsive Scale (time frame: baseline, 3 or 4 months, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.