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

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ClinicalTrials.gov Identifier: NCT01936051
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jun Soo Kwon, Seoul National University Hospital

Tracking Information
First Submitted Date August 27, 2013
First Posted Date September 5, 2013
Last Update Posted Date April 8, 2019
Study Start Date February 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2013)
serotonin transporter occupancy [ Time Frame: 72hr after oral administration of escitalopram ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01936051 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 2, 2013)
  • genotype [ Time Frame: baseline ]
  • Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score [ Time Frame: baseline ]
    scale for the severity of Obsessive-compulsive symptoms
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients
Official Title Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood sample
Sampling Method Non-Probability Sample
Study Population OCD patients
Condition OCD
Intervention Not Provided
Study Groups/Cohorts OCD patients
OCD patients being treated with any dose of escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 2, 2013)
12
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01936051
Other Study ID Numbers H-1109-086-378
2011-0931 ( Other Identifier: Seoul National university Hospital IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jun Soo Kwon, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jun Soo Kwon, M.D, Ph.D Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date April 2019