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Completed

NCT Number: NCT01936051

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.

Completed

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Key information

Conditions

OCD

Age range

20 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. serotonin transporter occupancy

    Time frame: 72hr after oral administration of escitalopram

Secondary outcomes

  1. genotype

    Time frame: baseline

  2. Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score

    Time frame: baseline

    scale for the severity of Obsessive-compulsive symptoms

  3. serotonin transporter occupancy

    Time frame: within the first 24hrs after oral administration of escitalopram

    serotonin transporter occupancy measured at 5 hour and 24 hour after oral dose of escitalopram

  4. escitalopram plasma concentration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2013
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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