Pharmacogenomics Studies of Antidepressants

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01204086

Collaborator

Department of Health, Executive Yuan, R.O.C. (Taiwan) (Other)

200

Enrollment

Location

Arms

47.1

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Antidepressive Agents Pharmacogenetics Venlafaxine Fluoxetine	Drug: Venlafaxine Drug: Fluoxetine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Feb 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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