The Effects of Escitalopram on Cytokines (BAFH)
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Escitalopram
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring cytokine, depression, escitalopram
Eligibility Criteria
Inclusion Criteria:
- DSM-IV-defined Major depressive disorder, single episode
- Age 20-65
- Drug-naive
- Hamilton Depression Rating Scale exceeding 14 scores
Exclusion Criteria:
- Major medical disorders
- Substance use
- Pregnant
- Allergy to escitalopram
Sites / Locations
- Beitou Armed Forces HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Escitalopram
Arm Description
Escitalopram 10 mg/d to 20 mg/d
Outcomes
Primary Outcome Measures
The changes in cytokines
Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α
Secondary Outcome Measures
The changes in Hamilton Depression Rating Scale
Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α
Full Information
NCT ID
NCT01587326
First Posted
April 26, 2012
Last Updated
May 13, 2012
Sponsor
Beitou Armed Forces Hospital, Taipei, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01587326
Brief Title
The Effects of Escitalopram on Cytokines
Acronym
BAFH
Official Title
The Effects of Escitalopram on Cytokines in Depressive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beitou Armed Forces Hospital, Taipei, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (MDD). Hence, the investigators will examine this association.
Detailed Description
In addition to serotonin, inflammatory process has been suggested in the development of major depressive disorder (MDD) and in its associated treatment. Escitalopram is an antidepressant that has been widely used in patients with MDD because of the promising results. The association of cytokines with escitalopram has not been investigated in patients with MDD. Hence, the investigators will examine this association.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
cytokine, depression, escitalopram
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Escitalopram 10 mg/d to 20 mg/d
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
escitalopram 10 mg/d to 20 mg/d
Primary Outcome Measure Information:
Title
The changes in cytokines
Description
Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α
Time Frame
Week 0, Week 4
Secondary Outcome Measure Information:
Title
The changes in Hamilton Depression Rating Scale
Description
Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α
Time Frame
week 0, week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV-defined Major depressive disorder, single episode
Age 20-65
Drug-naive
Hamilton Depression Rating Scale exceeding 14 scores
Exclusion Criteria:
Major medical disorders
Substance use
Pregnant
Allergy to escitalopram
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Shen Ho, M.D.
Phone
+886-2-28959808
Email
luke_and_tina@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peishen Ho, M.D.
Organizational Affiliation
Beitou Armed Forces Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beitou Armed Forces Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Sung Liang, M.D.
Phone
+886-2-8959808
Email
lcsyfw@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Effects of Escitalopram on Cytokines
We'll reach out to this number within 24 hrs