Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients

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.

Study Overview

• Status: Completed
• Conditions: OCD

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

OCD patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
OCD patients; OCD patients being treated with any dose of escitalopram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serotonin transporter occupancy	72hr after oral administration of escitalopram

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genotype		baseline
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score	scale for the severity of Obsessive-compulsive symptoms	baseline
serotonin transporter occupancy	serotonin transporter occupancy measured at 5 hour and 24 hour after oral dose of escitalopram	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	within 72 hours after oral administration of escitalopram

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jun Soo Kwon, M.D, Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: September 2, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: H-1109-086-378; 2011-0931 (Other Identifier: Seoul National university Hospital IRB)