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

This study has been withdrawn prior to enrollment.
(This study not get the approval by the drug company)
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00451490
First received: March 21, 2007
Last updated: December 24, 2007
Last verified: January 2007
  Purpose

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 Intervention
Depressive Disorder, Major
Drug: Agomelatine
Drug: Fluoxentine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Health Services Research
Official Title: The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • the Pittsburgh Sleep Quality Index
  • the Leeds Sleep Evaluation Questionnaire

Secondary Outcome Measures:
  • heart rate variability

Estimated Enrollment: 24
Study Start Date: October 2006
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00451490     History of Changes
Other Study ID Numbers: 200610027R
Study First Received: March 21, 2007
Last Updated: December 24, 2007
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on November 25, 2014