NCT01204086
Unknown
Phase 4
Pharmacogenomics Studies of Antidepressants
Overview
- Phase
- Phase 4
- Intervention
- Venlafaxine
- Conditions
- Major Depressive Disorder
- Sponsor
- National Cheng-Kung University Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Hamilton Depression Rating Scale (HDRS)
- Last Updated
- 15 years ago
Overview
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.
Investigators
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
Arms & Interventions
venlafaxine
Intervention: Venlafaxine
fluoxetine
Intervention: Fluoxetine
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale (HDRS)
Time Frame: 6 weeks
Secondary Outcomes
- C-reactive Protein and IL-6(6 weeks)
- fasting blood glucose, lipid profiles(6 weeks)
Study Sites (1)
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