NCT00451490

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 8, 2008

Status Verified

January 1, 2007

First QC Date

March 21, 2007

Last Update Submit

December 24, 2007

Conditions

Depressive Disorder, Major

Keywords

agomelatinprozacheart rate variabilitymajor depressionsleepdepressive symptoms

Outcome Measures

Primary Outcomes (2)

  • the Pittsburgh Sleep Quality Index

  • the Leeds Sleep Evaluation Questionnaire

Secondary Outcomes (1)

  • heart rate variability

Interventions

AgomelatineDRUG
FluoxentineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

agomelatine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Mei-Chih Tseng, MD

    National Taiwan Univetsity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

October 1, 2006

Study Completion

December 1, 2007

Last Updated

January 8, 2008

Record last verified: 2007-01

Locations

TW(1)