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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01204086
Other study ID # HR-95-06
Secondary ID DOH96-TD-D-113-0
Status Recruiting
Phase Phase 4
First received September 15, 2010
Last updated September 15, 2010
Start date March 2007
Est. completion date February 2011

Study information

Verified date September 2010
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date February 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 65 Years
Eligibility 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 Design

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


Intervention

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.
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.

Locations

Country Name City State
Taiwan National Cheng-Kung University Hospital Tainan

Sponsors (2)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Depression Rating Scale (HDRS) baseline No
Primary Hamilton Depression Rating Scale (HDRS) 2 weeks No
Primary Hamilton Depression Rating Scale (HDRS) 4 weeks No
Primary Hamilton Depression Rating Scale (HDRS) 6 weeks No
Secondary C-reactive Protein and IL-6 baseline No
Secondary fasting blood glucose, lipid profiles baseline No
Secondary C-reactive Protein and IL-6 6 weeks No
Secondary fasting blood glucose, lipid profiles 6 weeks No
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