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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00451490

Enrollment

Registered

2007-03-23

Start date

2006-10-31

Completion date

2007-12-31

Last updated

2008-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Keywords

agomelatin, prozac, heart rate variability, major depression, sleep, depressive symptoms

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.

Interventions

DRUGAgomelatine

DRUGFluoxentine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
the Pittsburgh Sleep Quality Index	—
the Leeds Sleep Evaluation Questionnaire	—

Secondary

Measure	Time frame
heart rate variability	—

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026