NCT01936051

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

August 27, 2013

Last Update Submit

April 4, 2019

Conditions

OCD

Outcome Measures

Primary Outcomes (1)

  • serotonin transporter occupancy

    72hr after oral administration of escitalopram

Secondary Outcomes (4)

  • genotype

    baseline

  • Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score

    baseline

  • serotonin transporter occupancy

    within the first 24hrs after oral administration of escitalopram

  • escitalopram plasma concentration

    within 72 hours after oral administration of escitalopram

Study Arms (1)

OCD patients

OCD patients being treated with any dose of escitalopram

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

OCD patients

You may qualify if:

  • Diagnosis of OCD based on Diagnostic and Statistical Manual(DSM)-IV criteria
  • no change of escitalopram dosage in 6 weeks

You may not qualify if:

  • psychiatric comorbidity other than OCD
  • History of head injury, epilepsy, other general medical disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

Study Officials

  • Jun Soo Kwon, M.D, Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in OCD Patients

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 5, 2013

Study Start

February 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

KR(1)