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Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Doh Kwan Kim, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237275
First Posted: November 9, 2010
Last Update Posted: December 31, 2015
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.
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
  Purpose

First, the investigators examined the functional relevance of serotonin transporter polymorphisms by quantifying the activity of serotonin transporter in blood platelets of genotyped healthy volunteers and patients with major depression.

Second, the investigators studied response to SSRIs in relation to 5-HTTLPR genotype and also to the functional expression of 5-HTT in platelets.


Condition Intervention
Depression Continuous Antidepressant Abuse Adverse Reaction to Drug Drug: SSRI treated group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients

Resource links provided by NLM:


Further study details as provided by Doh Kwan Kim, Samsung Medical Center:

Primary Outcome Measures:
  • Antidepressant Response at 2,4,6 weeks [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Biological value at 0 and 6 weeks [ Time Frame: 6weeks ]

Estimated Enrollment: 300
Study Start Date: October 1999
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SSRI treated group
SSRI treated group are depressive patients treated with fluoxetine, paroxetine or sertraline
Drug: SSRI treated group
characterize in arm of a study (SSRI treated group)
Other Names:
  • fluoxetine_Prozac
  • paroxetine_Paxil, Seroxat
  • sertraline_Zoloft

Detailed Description:

The purpose of this study is

  1. to determine whether serotonin transporter genotypic or functional differences between depressive patients and normal controls were existed.
  2. to determine the relationship between serotonin transporter polymorphisms and serotonin transporter functional expression.
  3. to determine whether genomic or functional differences between drug responders and nonresponders predict the response of antidepressant
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
  • interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

  • received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
  • potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.
  Contacts and Locations
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): NCT01237275


Locations
Korea, Republic of
Samsung Medical Center
Kangnam, Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Doh Kwan Kim, M.D., Ph.D. Samsung Medical Center
  More Information

Responsible Party: Doh Kwan Kim, M.D.,Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01237275     History of Changes
Other Study ID Numbers: 1999-10-14
First Submitted: November 1, 2010
First Posted: November 9, 2010
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Doh Kwan Kim, Samsung Medical Center:
Pharmacogenomics
Prediction of Antidepressant Response
Depressed Patients

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Antidepressive Agents
Sertraline
Paroxetine
Fluoxetine
Psychotropic Drugs
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
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors