- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01587326
The Effects of Escitalopram on Cytokines (BAFH)
May 13, 2012 updated by: Beitou Armed Forces Hospital, Taipei, Taiwan
The Effects of Escitalopram on Cytokines in Depressive Patients
The association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (MDD).
Hence, the investigators will examine this association.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan
- Recruiting
- Beitou Armed Forces Hospital
-
Contact:
- Chih-Sung Liang, M.D.
- Phone Number: +886-2-8959808
- Email: lcsyfw@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Escitalopram
Escitalopram 10 mg/d to 20 mg/d
|
escitalopram 10 mg/d to 20 mg/d
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The changes in cytokines
Time Frame: Week 0, Week 4
|
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
|
Week 0, Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The changes in Hamilton Depression Rating Scale
Time Frame: week 0, week 4
|
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
|
week 0, week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Peishen Ho, M.D., Beitou Armed Forces Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Anticipated)
April 1, 2013
Study Completion (Anticipated)
April 1, 2013
Study Registration Dates
First Submitted
April 26, 2012
First Submitted That Met QC Criteria
April 27, 2012
First Posted (Estimate)
April 30, 2012
Study Record Updates
Last Update Posted (Estimate)
May 15, 2012
Last Update Submitted That Met QC Criteria
May 13, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Depression
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- BAFH-101-05
- BAFH (Other Identifier: Civilian Administration Division)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.