Pharmacogenomics Studies of Antidepressants | NCT01204086

Studies
Pharmacogenomics Studies of Antidepressants

NCT01204086

Sponsor

National Cheng-Kung University Hospital

Status

Unknown status

Last Update Posted

Sep 17, 2010Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Major Depressive Disorder
Antidepressive Agents
Pharmacogenetics
Venlafaxine
Fluoxetine

Interventions

Venlafaxine
Fluoxetine

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

ID	Type	Description	Link
DOH96-TD-D-113-041	Other Grant/Funding Number	Department of Health, Taiwan

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Dec 2010Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Sep 15, 2010

First Posted Date

Sep 17, 2010Estimated

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

Sep 15, 2010

Last Update Posted Date

Sep 17, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Cheng-Kung University HospitalOTHER

Collaborators

Name	Class
Department of Health, Executive Yuan, R.O.C. (Taiwan)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to establish the clinical effectiveness of antidepressants by pharmacogenomic approach, and to determine the levels of inflammatory factors between the baseline and the end point of the study in Taiwanese major depressive disorder (MDD) patients.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
venlafaxine	Experimental		Drug: Venlafaxine
fluoxetine	Experimental		Drug: Fluoxetine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venlafaxine	Drug	The initial dose of venlafaxine was 37.5 mg once daily for 4 days titrated to 75 mg once daily, which could be increased by 75 mg in divided doses to a maximal daily dose of 225 mg.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hamilton Depression Rating Scale (HDRS)		baseline
Hamilton Depression Rating Scale (HDRS)		2 weeks
Hamilton Depression Rating Scale (HDRS)		4 weeks
Hamilton Depression Rating Scale (HDRS)		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
C-reactive Protein and IL-6		baseline
fasting blood glucose, lipid profiles		baseline
C-reactive Protein and IL-6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 16-65 years old
Signed informed consent by patient or legal representative
Hamilton Rating Scale for Depression (HDRS) scores ≥ 16
A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry

Exclusion Criteria:

monoamine oxidase inhibitor or antidepressant treatment within two weeks prior to entering the study
A DSM-IV diagnosis of substance abuse within the past three months
An organic mental disease, mental retardation or dementia
A serious surgical condition or physical illness
Patients who were pregnant or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Po See Chen, MD	National Cheng-Kung University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cheng-Kung University Hospital	Recruiting	Tainan		704	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069470	Venlafaxine Hydrochloride
D005473	Fluoxetine

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided