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The Effects of Escitalopram on Cytokines (BAFH)

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 May 2012 by Beitou Armed Forces Hospital, Taipei, Taiwan.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587326
First Posted: April 30, 2012
Last Update Posted: May 15, 2012
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):
Beitou Armed Forces Hospital, Taipei, Taiwan
  Purpose
The association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (MDD). Hence, the investigators will examine this association.

Condition Intervention
Depression Drug: Escitalopram

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Escitalopram on Cytokines in Depressive Patients

Resource links provided by NLM:


Further study details as provided by Beitou Armed Forces Hospital, Taipei, Taiwan:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram
Escitalopram 10 mg/d to 20 mg/d
Drug: Escitalopram
escitalopram 10 mg/d to 20 mg/d
Other Name: Lexapro

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-IV-defined Major depressive disorder, single episode
  2. Age 20-65
  3. Drug-naive
  4. Hamilton Depression Rating Scale exceeding 14 scores

Exclusion Criteria:

  1. Major medical disorders
  2. Substance use
  3. Pregnant
  4. Allergy to escitalopram
  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): NCT01587326


Contacts
Contact: Pei-Shen Ho, M.D. +886-2-28959808 luke_and_tina@yahoo.com.tw

Locations
Taiwan
Beitou Armed Forces Hospital Recruiting
Taipei, Taiwan
Contact: Chih-Sung Liang, M.D.    +886-2-8959808    lcsyfw@gmail.com   
Sponsors and Collaborators
Beitou Armed Forces Hospital, Taipei, Taiwan
Investigators
Study Chair: Peishen Ho, M.D. Beitou Armed Forces Hospital
  More Information

Responsible Party: Beitou Armed Forces Hospital, Taipei, Taiwan
ClinicalTrials.gov Identifier: NCT01587326     History of Changes
Other Study ID Numbers: BAFH-101-05
BAFH ( Other Identifier: Civilian Administration Division )
First Submitted: April 26, 2012
First Posted: April 30, 2012
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Beitou Armed Forces Hospital, Taipei, Taiwan:
cytokine, depression, escitalopram

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Citalopram
Dexetimide
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