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The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00451490
Recruitment Status : Withdrawn (This study not get the approval by the drug company)
First Posted : March 23, 2007
Last Update Posted : January 8, 2008
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will increase HRV at the end of the treatment.

Condition or disease Intervention/treatment
Depressive Disorder, Major Drug: Agomelatine Drug: Fluoxentine

Detailed Description:
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will have equal efficacy in improvement of depressive symptoms and increasement of HRV at the end of the treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Health Services Research
Official Title: The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
Study Start Date : October 2006
Estimated Study Completion Date : December 2007



Primary Outcome Measures :
  1. the Pittsburgh Sleep Quality Index
  2. the Leeds Sleep Evaluation Questionnaire

Secondary Outcome Measures :
  1. heart rate variability


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asian patients
  • Male or female
  • 18 to 65 years outpatients
  • DSM-IV-TR criteria for Major Depressive Disorder

Exclusion Criteria:

  • Patients with cardiac conditions and other physical conditions contraindicated for drug study
  • Shift worker
  • Patients known to be non-responders to fluoxetine treatment
  • Pregnancy, or breastfeeding

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): NCT00451490


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Mei-Chih Tseng, MD National Taiwan Univetsity Hospital

ClinicalTrials.gov Identifier: NCT00451490     History of Changes
Other Study ID Numbers: 200610027R
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: January 8, 2008
Last Verified: January 2007

Keywords provided by National Taiwan University Hospital:
agomelatin
prozac
heart rate variability
major depression
sleep
depressive symptoms

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs