Pharmacogenomics Studies of Antidepressants

NCT ID: NCT01204086

Last Updated: 2010-09-17

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Major Depressive Disorder Antidepressive Agents Pharmacogenetics Venlafaxine Fluoxetine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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venlafaxine

Group Type EXPERIMENTAL

Venlafaxine

Intervention Type 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.

fluoxetine

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

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.

Interventions

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Venlafaxine

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

Fluoxetine

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Cheng-Kung University Hospital

Principal Investigators

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Po See Chen, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

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National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Po See Chen, MD

Role: primary

+886-6-2353535 ext. 5213

Other Identifiers

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DOH96-TD-D-113-041

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HR-95-06

Identifier Type: -

Identifier Source: org_study_id