Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease
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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Other
Time Perspective: Other
Official Title: Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013


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



Primary Outcome Measures :
  1. serotonin transporter occupancy [ Time Frame: 72hr after oral administration of escitalopram ]

Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
blood sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
OCD patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936051


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jun Soo Kwon, M.D, Ph.D Seoul National University Hospital

Layout table for additonal information
Responsible Party: Jun Soo Kwon, Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in OCD Patients, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01936051     History of Changes
Other Study ID Numbers: H-1109-086-378
2011-0931 ( Other Identifier: Seoul National university Hospital IRB )
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Dexetimide
Citalopram
Serotonin
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin Receptor Agonists