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Pharmacogenomics Studies of Antidepressants

Primary Purpose

Major Depressive Disorder, Antidepressive Agents, Pharmacogenetics

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Venlafaxine

Fluoxetine

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Antidepressants, Pharmacogenetics, venlafaxine, fluoxetine

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cheng-Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

venlafaxine

fluoxetine

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS)

Secondary Outcome Measures

C-reactive Protein and IL-6

fasting blood glucose, lipid profiles

C-reactive Protein and IL-6

fasting blood glucose, lipid profiles

Full Information

NCT ID

NCT01204086

First Posted

September 15, 2010

Last Updated

September 15, 2010

Sponsor

National Cheng-Kung University Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01204086

Brief Title

Pharmacogenomics Studies of Antidepressants

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cheng-Kung University Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Antidepressive Agents, Pharmacogenetics, Venlafaxine, Fluoxetine

Keywords

Major Depressive Disorder, Antidepressants, Pharmacogenetics, venlafaxine, fluoxetine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

venlafaxine

Arm Type

Experimental

Arm Title

fluoxetine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Venlafaxine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Fluoxetine

Intervention Description

The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 80 mg.

Primary Outcome Measure Information:

Title

Hamilton Depression Rating Scale (HDRS)

Time Frame

baseline

Title

Hamilton Depression Rating Scale (HDRS)

Time Frame

2 weeks

Title

Hamilton Depression Rating Scale (HDRS)

Time Frame

4 weeks

Title

Hamilton Depression Rating Scale (HDRS)

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

C-reactive Protein and IL-6

Time Frame

baseline

Title

fasting blood glucose, lipid profiles

Time Frame

baseline

Title

C-reactive Protein and IL-6

Time Frame

6 weeks

Title

fasting blood glucose, lipid profiles

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Po See Chen, MD

Organizational Affiliation

National Cheng-Kung University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cheng-Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Po See Chen, MD

Phone

+886-6-2353535

Ext

5213

chenps@mail.ncku.edu.tw

First Name & Middle Initial & Last Name & Degree

Po See Chen, MD

12. IPD Sharing Statement

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Pharmacogenomics Studies of Antidepressants

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