Pharmacogenomics Studies of Antidepressants

Phase 4

• Conditions: Major Depressive Disorder; Antidepressive Agents; Pharmacogenetics; Venlafaxine; Fluoxetine
• Interventions: Drug: Venlafaxine; Drug: Fluoxetine

• Registration Number: NCT01204086
• Lead Sponsor: National Cheng-Kung University Hospital

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 available

Study Timeline

• Study Start: 2007-03
• Status Verified: 2010-09
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Last Update Submitted: 2010-09-15
• Study First Posted: 2010-09-17
• Last Update Posted: 2010-09-17
• Primary Completion: 2010-12
• Study Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
venlafaxine	Venlafaxine	-
fluoxetine	Fluoxetine	-

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS)	6 weeks

Secondary Outcome Measures

Name	Time	Method
C-reactive Protein and IL-6	6 weeks
fasting blood glucose, lipid profiles	6 weeks

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan