Pharmacogenomics Studies of Antidepressants

National Cheng-Kung University

Status and phase: Unknown; Phase 4

Conditions: Venlafaxine; Antidepressive Agents; Major Depressive Disorder; Fluoxetine; Pharmacogenetics

Treatments: Drug: Fluoxetine; Drug: Venlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT01204086

HR-95-06

DOH96-TD-D-113-041 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

venlafaxine

Experimental group

Treatment:

Drug: Venlafaxine

fluoxetine

Experimental group

Treatment:

Drug: Fluoxetine