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Clinical Trials/NCT01204086
NCT01204086
Unknown
Phase 4

Pharmacogenomics Studies of Antidepressants

National Cheng-Kung University Hospital1 site in 1 country200 target enrollmentMarch 2007

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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
February 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

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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