The Effect of Agomelatine or Fluoxentine on Heart Rate Va... | NCT00451490

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

NCT00451490

Sponsor

National Taiwan University Hospital

Status

Withdrawn

Last Update Posted

Jan 8, 2008Estimated

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Depressive Disorder, Major

Interventions

Agomelatine
Fluoxentine

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study not get the approval by the drug company

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Dec 2007Estimated

First Submitted Date

Mar 21, 2007

First Submission Date that Met QC Criteria

Mar 22, 2007

First Posted Date

Mar 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2007

Last Update Posted Date

Jan 8, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Measure	Description	Time Frame
heart rate variability

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mei-Chih Tseng, MD	National Taiwan Univetsity Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C084711	agomelatine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
the Pittsburgh Sleep Quality Index
the Leeds Sleep Evaluation Questionnaire