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

Completed

• Conditions: OCD

• Registration Number: NCT01936051
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-05
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serotonin transporter occupancy	72hr after oral administration of escitalopram

Secondary Outcome Measures

Name	Time	Method
genotype	baseline
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score	baseline	scale for the severity of Obsessive-compulsive symptoms
serotonin transporter occupancy	within the first 24hrs after oral administration of escitalopram	serotonin transporter occupancy measured at 5 hour and 24 hour after oral dose of escitalopram
escitalopram plasma concentration	within 72 hours after oral administration of escitalopram	plasma concentration of escitalopram at baseline, 1, 2, 3, 5, 8, 10, 24, 48, 72 hour after oral dose of escitalopram

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of