Pharmacogenomics Studies of Antidepressants
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Mar 2007
Longer than P75 for phase_4 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedSeptember 17, 2010
September 1, 2010
3.8 years
September 15, 2010
September 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Hamilton Depression Rating Scale (HDRS)
baseline
Hamilton Depression Rating Scale (HDRS)
2 weeks
Hamilton Depression Rating Scale (HDRS)
4 weeks
Hamilton Depression Rating Scale (HDRS)
6 weeks
Secondary Outcomes (4)
C-reactive Protein and IL-6
baseline
fasting blood glucose, lipid profiles
baseline
C-reactive Protein and IL-6
6 weeks
fasting blood glucose, lipid profiles
6 weeks
Study Arms (2)
venlafaxine
EXPERIMENTALfluoxetine
EXPERIMENTALInterventions
The initial dose of venlafaxine was 37.5 mg once daily for 4 days titrated to 75 mg once daily, which could be increased by 75 mg in divided doses to a maximal daily dose of 225 mg.
The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 80 mg.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng-Kung University Hospital
Tainan, 704, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Po See Chen, MD
National Cheng-Kung University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 15, 2010
First Posted
September 17, 2010
Study Start
March 1, 2007
Primary Completion
December 1, 2010
Study Completion
February 1, 2011
Last Updated
September 17, 2010
Record last verified: 2010-09