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

OCD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936051
• Other study ID #: H-1109-086-378
• Secondary ID: 2011-0931
• Status: Completed
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• OCD

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serotonin transporter occupancy		72hr after oral administration of escitalopram
Secondary	genotype		baseline
Secondary	Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score	scale for the severity of Obsessive-compulsive symptoms	baseline
Secondary	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
Secondary	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