Pharmacogenomics Studies of Antidepressants

Phase 4UnknownNCT01204086

National Cheng-Kung University Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Major Depressive Disorder Antidepressive Agents Pharmacogenetics Venlafaxine Fluoxetine

Interventions

VenlafaxineDRUG

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.

FluoxetineDRUG

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.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cheng-Kung University Hospital

Tainan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale (HDRS)

Time frame: baseline

Hamilton Depression Rating Scale (HDRS)

Time frame: 2 weeks

Hamilton Depression Rating Scale (HDRS)

Time frame: 4 weeks

Hamilton Depression Rating Scale (HDRS)

Time frame: 6 weeks

Secondary Outcomes

C-reactive Protein and IL-6

Time frame: baseline

fasting blood glucose, lipid profiles

Time frame: baseline

C-reactive Protein and IL-6

Time frame: 6 weeks

fasting blood glucose, lipid profiles

Time frame: 6 weeks

Data from ClinicalTrials.gov

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