OCDNCT01936051
Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients
An observational study of OCD, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma concentration and the transporter occupancy from OCD patients treated with escitalopram. To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the PK-PD modeling in OCD patients treated with escitalopram. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men only
- Conditions the study is for
- OCD
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 35 years
- Men only
- No healthy volunteers
- Adult
Study population: OCD patients
Who may be able to join
- Diagnosis of OCD based on Diagnostic and Statistical Manual(DSM)-IV criteria
- no change of escitalopram dosage in 6 weeks
Who cannot join
- psychiatric comorbidity other than OCD
- History of head injury, epilepsy, other general medical disorder
Trial locations and contacts
1 site in 1 country.
About this study
To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma concentration and the transporter occupancy from OCD patients treated with escitalopram.
To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the PK-PD modeling in OCD patients treated with escitalopram.
Read the detailed description
To measure plasma concentration of escitalopram in OCD patients treated with escitalopram.
To measure serotonin transporter occupancy by escitalopram in OCD patients treated with escitalopram.
To genotype G2677T/A SNP of ABCB1 gene in OCD patients treated with escitalopram.
- Conditions
- OCD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OCD patients | OCD patients being treated with any dose of escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
serotonin transporter occupancy
Measured: 72hr after oral administration of escitalopram
Secondary outcomes (4)
genotype
Measured: baseline
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score
scale for the severity of Obsessive-compulsive symptoms
Measured: baseline
serotonin transporter occupancy
serotonin transporter occupancy measured at 5 hour and 24 hour after oral dose of escitalopram
Measured: within the first 24hrs after oral administration of escitalopram
escitalopram plasma concentration
plasma concentration of escitalopram at baseline, 1, 2, 3, 5, 8, 10, 24, 48, 72 hour after oral dose of escitalopram
Measured: within 72 hours after oral administration of escitalopram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCDStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Soo Kwon, Seoul National University Hospital
- Investigators
- Jun Soo Kwon, M.D, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936051
- Sponsor's protocol ID
- H-1109-086-378
- Other IDs
- 2011-0931
- Status last verified
- Apr 2019
- First submitted
- 27 Aug 2013
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients
- ClinicalTrials.gov ID
- NCT01936051
- Acronym / sponsor ID
- H-1109-086-378
- Conditions
- OCD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Sep 2013 (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.
To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma concentration and the transporter occupancy from OCD patients treated with escitalopram.
To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the PK-PD modeling in OCD patients treated with escitalopram.
Detailed description
To measure plasma concentration of escitalopram in OCD patients treated with escitalopram.
To measure serotonin transporter occupancy by escitalopram in OCD patients treated with escitalopram.
To genotype G2677T/A SNP of ABCB1 gene in OCD patients treated with escitalopram.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCD patients | – | –OCD patients being treated with any dose of escitalopram |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- OCD patients
Key inclusion criteria (2 listed)
- Diagnosis of OCD based on Diagnostic and Statistical Manual(DSM)-IV criteria
- no change of escitalopram dosage in 6 weeks
Key exclusion criteria (2 listed)
- psychiatric comorbidity other than OCD
- History of head injury, epilepsy, other general medical disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serotonin transporter occupancy
Time frame: 72hr after oral administration of escitalopram
4 secondary outcomes
genotype
Time frame: baseline
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score
Time frame: baseline
serotonin transporter occupancy
Time frame: within the first 24hrs after oral administration of escitalopram
escitalopram plasma concentration
Time frame: within 72 hours after oral administration of escitalopram
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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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. This study is not recruiting at the moment.
Jun Soo Kwon, M.D, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OCD, run by Seoul National University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serotonin transporter occupancy (time frame: 72hr after oral administration of escitalopram). 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 8 Apr 2019.