The Effects of Escitalopram on Cytokines (BAFH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Beitou Armed Forces Hospital, Taipei, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Beitou Armed Forces Hospital, Taipei, Taiwan
ClinicalTrials.gov Identifier:
NCT01587326
First received: April 26, 2012
Last updated: May 13, 2012
Last verified: May 2012
  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: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Beitou Armed Forces Hospital, Taipei, Taiwan
ClinicalTrials.gov Identifier: NCT01587326     History of Changes
Other Study ID Numbers: BAFH-101-05, BAFH
Study First Received: April 26, 2012
Last Updated: May 13, 2012
Health Authority: Taiwan : Food and Drug Administration

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 27, 2014