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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00451490
• Other study ID #: 200610027R
• Status: Withdrawn
• Phase: N/A
• First received: March 21, 2007
• Last updated: December 24, 2007
• Start date: October 2006
• Est. completion date: December 2007

Study information

• Verified date: January 2007
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 24
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Agomelatine

• Fluoxentine

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Pittsburgh Sleep Quality Index
Primary	the Leeds Sleep Evaluation Questionnaire
Secondary	heart rate variability