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Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
antidepressant response
antidepressant non-response
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Antidepressant Response, Signal Transduction, Lymphocyte, Biomarkers, Depressed Patients, Antidepressant Drug Adverse Reaction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea.
  2. were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents

Exclusion Criteria:

  • pregnancy
  • significant medical conditions
  • abnormal laboratory baseline values
  • unstable psychiatric features (e.g, suicidal attempt)
  • history of alcohol or drug dependence, seizure, neurological illness, or concomitant Axis I psychiatric disorder

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

antidepressant response

antidepressant non-response

Arm Description

antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score

antidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score

Outcomes

Primary Outcome Measures

Antidepressant Response at 6 weeks
Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or >50% Measurement Unit = responders, nonresponders

Secondary Outcome Measures

Biological value at 0 and 6 weeks
Biologial value is defined as protein expression value of signaling components in peripheral lymphocyte. Measurement value : Optical Density(O.D), microgram/liter(ug/l)

Full Information

First Posted
April 21, 2011
Last Updated
December 30, 2015
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01352572
Brief Title
Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients
Official Title
Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration, or represent the clinical status of depressed patients.
Detailed Description
The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Antidepressant Response, Signal Transduction, Lymphocyte, Biomarkers, Depressed Patients, Antidepressant Drug Adverse Reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
antidepressant response
Arm Type
Experimental
Arm Description
antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score
Arm Title
antidepressant non-response
Arm Type
Active Comparator
Arm Description
antidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score
Intervention Type
Drug
Intervention Name(s)
antidepressant response
Other Intervention Name(s)
fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, milnacipran, venlafaxine_Effexor, nortriptyline_Aventyl, Pamelor, Noritren, mirtazapine_Avanza, Zispin, Remeron
Intervention Description
Antidepressants administration for 6 weeks under therapeutic dose responders
Intervention Type
Drug
Intervention Name(s)
antidepressant non-response
Other Intervention Name(s)
fluoxetine, paroxetine, sertraline, milnacipran, venlafaxine, nortriptyline, mirtazapine
Intervention Description
Antidepressants administration for 6 weeks under therapeutic dose nonresponders
Primary Outcome Measure Information:
Title
Antidepressant Response at 6 weeks
Description
Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or >50% Measurement Unit = responders, nonresponders
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Biological value at 0 and 6 weeks
Description
Biologial value is defined as protein expression value of signaling components in peripheral lymphocyte. Measurement value : Optical Density(O.D), microgram/liter(ug/l)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea. were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents Exclusion Criteria: pregnancy significant medical conditions abnormal laboratory baseline values unstable psychiatric features (e.g, suicidal attempt) history of alcohol or drug dependence, seizure, neurological illness, or concomitant Axis I psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doh Kwan Kim, MD PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Kangnam
State/Province
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

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