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

Not Applicable

Withdrawn

• Conditions: Depressive Disorder, Major

• Registration Number: NCT00451490
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2006-10
• Status Verified: 2007-01
• Study First Submitted: 2007-03-21
• Study First Submitted QC: 2007-03-22
• Study First Posted: 2007-03-23
• Study Completion: 2007-12
• Last Update Submitted: 2007-12-24
• Last Update Posted: 2008-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the Pittsburgh Sleep Quality Index
the Leeds Sleep Evaluation Questionnaire

Secondary Outcome Measures

Name	Time	Method
heart rate variability

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan