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WithdrawnNCT00451490Updated Jan 8, 2008

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

An interventional study of Agomelatine and Fluoxentine in Depressive Disorder, Major, sponsored by National Taiwan University Hospital. Withdrawn at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-01-08.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Health services research

Why this study was withdrawn
This study not get the approval by the drug company
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depressive Disorder, Major

Keywords

  • agomelatin
  • prozac
  • heart rate variability
  • major depression
  • sleep
  • depressive symptoms
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's planned enrollment of 24 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Asian patients
  • Male or female
  • 18 to 65 years outpatients
  • DSM-IV-TR criteria for Major Depressive Disorder

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
24 participants (estimated)

Interventions

  • DrugAgomelatine
  • DrugFluoxentine
06

What researchers measure

Primary outcomes

  1. the Pittsburgh Sleep Quality Index

  2. the Leeds Sleep Evaluation Questionnaire

Secondary outcomes

  1. heart rate variability

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00451490
Lead sponsor
National Taiwan University Hospital
First posted
Mar 23, 2007
Start date
Oct 2006
Completion
Dec 2007 (estimated)
Last update
Jan 8, 2008

Study contacts

Mei-Chih Tseng, MD
principal investigator · National Taiwan Univetsity Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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