Back to resultsThe Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
Primary Purpose
Depressive Disorder, Major
Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Agomelatine
Fluoxentine
Sponsored by
About this trial
This is an interventional health services research trial for Depressive Disorder, Major focused on measuring agomelatin, prozac, heart rate variability, major depression, sleep, depressive symptoms
Eligibility 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
Sites / Locations
- National Taiwan University Hospital
Outcomes
Primary Outcome Measures
the Pittsburgh Sleep Quality Index
the Leeds Sleep Evaluation Questionnaire
Secondary Outcome Measures
heart rate variability
Full Information
NCT ID
NCT00451490
First Posted
March 21, 2007
Last Updated
December 24, 2007
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00451490
Brief Title
The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
Official Title
The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Withdrawn
Why Stopped
This study not get the approval by the drug company
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
agomelatin, prozac, heart rate variability, major depression, sleep, depressive symptoms
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Agomelatine
Intervention Type
Drug
Intervention Name(s)
Fluoxentine
Primary Outcome Measure Information:
Title
the Pittsburgh Sleep Quality Index
Title
the Leeds Sleep Evaluation Questionnaire
Secondary Outcome Measure Information:
Title
heart rate variability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Chih Tseng, MD
Organizational Affiliation
National Taiwan Univetsity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
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