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Pharmacogenomics Studies of Antidepressants

Information source: National Cheng-Kung University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Antidepressive Agents; Pharmacogenetics; Venlafaxine; Fluoxetine

Intervention: Venlafaxine (Drug); Fluoxetine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Cheng-Kung University Hospital

Official(s) and/or principal investigator(s):
Po See Chen, MD, Principal Investigator, Affiliation: National Cheng-Kung University Hospital

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Hamilton Depression Rating Scale (HDRS)

Hamilton Depression Rating Scale (HDRS)

Hamilton Depression Rating Scale (HDRS)

Hamilton Depression Rating Scale (HDRS)

Secondary outcome:

C-reactive Protein and IL-6

fasting blood glucose, lipid profiles

C-reactive Protein and IL-6

fasting blood glucose, lipid profiles

Eligibility

Minimum age: 16 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

National Cheng-Kung University Hospital, Tainan 704, Taiwan; Recruiting
Po See Chen, MD, Phone: +886-6-2353535, Ext: 5213, Email: chenps@mail.ncku.edu.tw
Po See Chen, MD, Principal Investigator
Additional Information

Starting date: March 2007
Last updated: September 15, 2010

Page last updated: August 23, 2015

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