Pharmacogenomics Studies of Antidepressants

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.

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder; Pharmacogenetics; Antidepressive Agents; Fluoxetine; Venlafaxine
• Intervention / Treatment: Drug: Venlafaxine; Drug: Fluoxetine

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: venlafaxine	Drug: Venlafaxine; 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.
Experimental: fluoxetine	Drug: Fluoxetine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Collaborators: Department of Health, Executive Yuan, R.O.C. (Taiwan)
• Investigators: Principal Investigator: Po See Chen, MD, National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Estimate): September 17, 2010
• Last Update Submitted That Met QC Criteria: September 15, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Pharmacogenetics; Major Depressive Disorder; fluoxetine; Antidepressants; venlafaxine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Cytochrome P-450 CYP2D6 Inhibitors; Venlafaxine Hydrochloride; Fluoxetine
• Other Study ID Numbers: HR-95-06; DOH96-TD-D-113-041 (Other Grant/Funding Number: Department of Health, Taiwan)