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

NCT ID: NCT00451490

Last Updated: 2008-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Interventions

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Agomelatine

Intervention Type DRUG

Fluoxentine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Mei-Chih Tseng, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Univetsity Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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200610027R

Identifier Type: -

Identifier Source: org_study_id

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