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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00451490

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major	Drug: Agomelatine Drug: Fluoxentine	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2006

Anticipated Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

the Pittsburgh Sleep Quality Index []
the Leeds Sleep Evaluation Questionnaire []

Secondary Outcome Measures

heart rate variability []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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