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

This study has been withdrawn prior to recruitment.

( This study not get the approval by the drug company )

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00451490

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

MedlinePlus related topics: Depression

Drug Information available for: S 20098

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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

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

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

Keywords provided by National Taiwan University Hospital:

agomelatin
prozac
heart rate variability
major depression

heart rate variability
sleep
depressive symptoms

Study placed in the following topic categories:

Fluoxetine
S 20098
Depression
Mental Disorders

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Hypnotics and Sedatives
Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009